Glaukos jobs in Aliso Viejo, CA - 55 jobs

How you will make an impact: The Clinical Trials Associate II is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director. What you will you: Clinical Study Preparation and Maintenance * Assists with review of clinical trial protocols * Assists with development/review of source documents * Assists with preparation of Informed Consent Forms * Assists with development of recruitment materials and study tools * Works with cross functional team members as assigned * Works with study vendors as assigned Collection and Review of Site Start-Up Documents * Communicates directly with site staff to obtain site start-up documents * Negotiates study contract and budget * Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV) Receives, QC's, and files site documents in Study Master File * Provides status of site documents in Study Master File to Clinical Research Associates (CRAs) prior to Monitoring Visits Clinical Site Management * CTA is responsible for effective communication with clinical trial sites * Obtains site documents from Clinical Research Associates during trial * Addresses inquiries from sites and CRAs * Escalates issues to study management as needed Study Master File Maintenance * Sets up Study Master File and Study Master File Tracker at the beginning of each study * Receives, QC's, scans and files documents in Study Master File * Provides status of documents to Clinical Management Establishes and Maintains Tracking of Trial Information * Team and site contact information * Site status information * Equipment and supplies Enrollment trackers * Adverse event trackers * Site payment trackers and site payments How You'll Get There: * Bachelor's Degree with background in science, or equivalent work experience preferred * 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field #GKOSUS

GLAUKOS - REIMBURSEMENT LIAISON (GLAUCOMA) - 6 OPENINGS!! "We'll Go First" (***************************** How will you make an impact? The Reimbursement Liaison will serve as an expert in reimbursement policies, as well as patient and provider support, to ensure patients have access to Glaukos' sight saving technologies. The Reimbursement Liaison works with physician practices (both private and hospital affiliated institutions). They interact directly with key management personnel, providers and staff members to assure patient access to care. This individual appropriately educates HCPs and their office staff on clinical documentation, securing treatment approvals, patient tracking, claim submission, reconciliation management, patient education, drug inventory, patient copay assistance and drug acquisition channels. This position helps HCPs understand barriers that may impede or delay appropriate patient access to treatment and/or prevent optimal patient outcomes. Additionally, the Reimbursement Liaison provides education on appropriate and accurate billing and coding practices for Glaukos' products in line with payer requirements to the highest levels of specificity. This candidate must be organized and detail oriented. Demonstrated teamwork and collaboration abilities with high emotional intelligence in managing multiple business initiatives and cross-functional relationships will be a requirement. What will you do? Specific responsibilities include but are not limited to: Provides HCPs and their office staff education on how to interpret benefit verifications including PA requirements, calculation of patient cost share and drug acquisition options for specific patients enrolled in GPS. Collaborates with Patient Support Specialist (PSS) to identify and eliminate barriers to access for patients enrolled in GPS. Responds to HCP questions related to coding, payer policy, and approval protocols. Offers expertise on navigating copay assistance for appropriate patients enrolled in GPS. Provides education on navigating the appeals process as well as denied and partially paid claims. Takes lead in completing Business Reviews and Claims Reviews for practices. Provides education on specialty pharmacy and buy & bill acquisition options. Monitors reimbursement trends (e.g., HCPs receiving notification of policy changes, claim denials, underpayments, etc.) and engages payer team appropriately when patient access may be jeopardized. Maintains expertise in regional and national payer landscapes, specifically, proper clinical requirements, reimbursement policy, utilization management criteria, prior authorization processes and appeal requirements. Updates customers on policy changes through approved templates and plan approval. Identifies coverage gaps and computer errors on policy requirements or portal entry challenges that inhibit patient access to care. Manages all forms of communication in a timely and professional fashion to ensure customer needs are fully met and all relevant internal stakeholders are appropriately updated. Demonstrates positive leadership, without authority, to peers, upper management and other stakeholders by leveraging skills and expertise in account management. Successfully completes assigned training. The Reimbursement Liaison consistently demonstrates uncompromised ethics and integrity while helping others understand legal and regulatory parameters related to anti-kickback statutes, fraud and abuse, off-label promotion, and OIG guidance related to patient assistance programs. How will you get here? Bachelors Degree in related field. MBA or MPH preferred. 8+ years of experience working with specialty pharmaceuticals or surgical devices required. Minimum of 3 years “direct” reimbursement/healthcare policy experience required. Previous sales, district management, field reimbursement, hospital or practice experience preferred. Eyecare experience preferred. Reimbursement experience with physician-administered injectables and/or medical devices, Category III CPT codes and/or miscellaneous J-codes, specialty pharmacy and buy & bill acquisition, and benefit verifications, prior authorizations, claims assistance, and appeals. Payer/insurance coverage experience with Medicare, Medicare Advantage, VA/Tri-Care, Commercial and Medicaid plans. Ability to travel adequately to cover territory, as well as overnight travel (~50%) and attendance at scheduled training and meetings. Proven record of accomplishment in achieving objectives and corporate goals with minimal direct supervision. Demonstrated creativity, situation analysis/problem solving skills and analytical skill ability. Excellent communication skills, including written, verbal and listening. Strong presentation and training skills. Demonstrated leadership and project management skills. Significant experience working with a Patient Service Center/Hub. Successful navigation of complex authorization processes for specialty medications, Orphan, or Rare disease. Educate Healthcare Professionals on the availability of patient support programs such as Co-Pay Assistance and Patient Assistance Programs. #GKOSUS #LI-Remote

Who we are A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Genentech is the founder of the biotechnology industry and has been delivering on the promise of biotechnology for more than 43 years. It has been a member of the Roche Group since 2009 and is one of its most important centres of pharmaceutical research. At Roche, the patient is at the heart of all R&D efforts, and delivering life-changing therapies to patients while also driving positive change in the global society is the impetus to everything we do. The Opportunity As a Manufacturing Technician, you will work within a team to produce and deliver quality products for patients around the world. We are a 24/7 site and the work load is divided across multiple organizations. Technicians are expected to work in a safe manner and follow our Standard Operating Procedures at all times. Doing these two critical aspects of our job helps us maintain our right to operate and commitment to governing bodies around the world. Our Manufacturing begins in Upstream, where we thaw and scale up our process. Some of the responsibilities for Upstream technicians are: preparing the medium needed for cell growth and maintaining our Cell Cultures which includes the set-up and breakdown of stainless steel bioreactors. In Downstream, technicians work on a series of operations to isolate, purify, and concentrate the product. This includes preparation of Buffers, cleaning and steaming in place Chromatography skids, and supporting formulation. Who you are: You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your own interests; where a job title is not considered the final definition of who you are, but the starting point. Experience with biologics manufacturing is not necessary but preferred. Candidates must be able to work any of the following manufacturing shifts: * 12 hr Day Shift, 6:00 am - 7:00 pm, * Sunday -Tuesday plus every other Wednesday * Wednesday - Friday plus every other Saturday * 10 hr Day Shift, 6:00 am - 4:30 pm * Sunday - Wednesday * Wednesday - Saturday * 10 hr Swing Shift, 3:30 pm -2:00 am * Sunday - Wednesday * Wednesday - Saturday * 12 hr Night Shift, 6:00 pm -7:00 am * Sunday-Tuesday plus every other Saturday * Wednesday - Friday plus every other Saturday Onboarding practices vary with area, but may consist of a multi-week schedule of Monday - Friday 8am - 5pm followed by on the job training for multiple weeks Monday - Thursday or Tuesday - Friday 1:00pm - 11:30pm. Once onboarding and/or training is complete, you will be released to your assigned Manufacturing shift. Shift availability will be determined by matching candidates strengths to shift needs and are subject to change based on business needs and production schedules. Shift availability will be determined by matching candidates strengths to shift needs and subject to change based on business needs. Behaviors, competencies, and qualities of the ideal applicant: * Hardworking and fast learning individual that thrives in a high paced environment * Experience in clean room environment and familiarity with cGMP and ISO/FDA standards is strongly preferred * Ability to think critically and work both tactically and strategically * Strong quality mindset with attention to detail and a desire to deliver service excellence * Ability to work effectively with others, exhibiting a professional manner and establish constructive working relationships Qualifications / Requirements: * Proficiency in the English language- reading, writing, and communication. * Must be able to work all shifts, required overtime as needed, and stand for extended periods of time. * Must be able to interface with computer systems to successfully operate manufacturing equipment. Experience with distributed control systems or other manufacturing automation is preferred. * Must be able to successfully pass all job-related tests and certifications required for working in a cGMP quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job. * Must re-qualify every year on all job-related training and certifications as job or qualifications require. * May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility. * Lifting up to 25lbs may be required. * The cleanroom environment requires that company provided gowning is worn. This may include plant uniform, coveralls, gloves and safety shoes. Additionally, regulations prohibit makeup, jewelry, and other personal items from entering the clean room environment. Education: * Bachelor's degree in Life Sciences or Engineering and 1 year related experience, or associates degree and 3 years of experience, or High School and 5 years experience. * Biotech certificate from approved program Work Experience: * Experience in a GMP working environment with Background in Cell Culture/Purification is highly desired for 2-4 years (within the last 7 years) experience in the operation of complex mechanical equipment used in the washing, autoclaving, and assembly of parts used in Upstream or Downstream processes. * Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries. * Understands the theory, concepts, and regulations behind biopharma technology and processes. Computers: * Must be computer literate, including ability to interface with computer systems such as Delta-V and PLC-based logic. * Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. * Must possess basic typing skills and understand Google platforms. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of California is $42,400 to $70,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

GLAUKOS - HUMAN FACTORS SPECIALIST I At Glaukos, we're committed to advancing innovative ocular therapies that improve patients' quality of life. As part of our Research & Development team, the Human Factors Specialist ensures our products are safe, intuitive, and designed with the end user in mind. In this role, you'll collaborate across disciplines to transform insights from clinicians and patients into meaningful design solutions that support global regulatory compliance and exceptional product performance. How will you make an impact? The Human Factors Specialist will perform a variety of Human Factors / Usability Engineering (HFUE) validation activities based on Risk Management of ocular related products to support product design, concept testing, early development, clinical testing, and sustaining activities. The Specialist play a key role in ensuring the safety, effectiveness, and ease of use of our ocular-related medical and combination products. By applying human factors and usability engineering principles, you'll help shape product designs that meet user needs, reduce risk, and comply with global regulatory standards. Your work will directly influence how our products perform in the hands of clinicians and patients worldwide. What will you do? Plan and execute human factors and usability engineering (HFUE) studies, including formative and summative evaluations. Identify and assess use-related risks and recommend design improvements throughout product development. Partner with engineering, design, quality, regulatory, and medical safety teams to ensure user needs and risk controls are effectively integrated. Prepare and maintain HFUE documentation including protocols, reports, and design control deliverables. Support design control, verification, validation, and risk management activities in alignment with FDA and ISO standards (e.g., IEC 62366, HE75, EN ISO 14971). Advocate for end users through data collection, usability analysis, and application of user-centered design best practices. How will you get here? Bachelor's degree in Engineering (Chemical, Biomedical, or related field). 0-2 years of experience; at least 1 year of HFUE experience preferred. Knowledge of human factors and usability standards and medical device regulations (FDA HFUE Guidance, IEC 62366, HE75, EN ISO 14971). Experience with ocular devices, wet/dry lab setups, or cross-functional product development a plus. Strong analytical, communication, and documentation skills. Proficiency in Microsoft Office Suite. HFUE coursework or certification preferred. #GKOSUS

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Medical Science Liaison / Field Medical Advisor - Corneal Health (East Region) This field-based role at Glaukos is responsible for engaging with key opinion leaders (KOLs) in optometry and ophthalmology, providing scientific and clinical expertise on disease states and Glaukos products. The position involves building and managing relationships, supporting clinical evidence studies, and contributing to strategic planning and process improvement for the Medical Safety team. Responsibilities include: Acting as a subject matter expert for internal and external stakeholders Delivering compliant scientific education and responding to medical inquiries Supporting and mentoring new team members Gathering actionable insights and supporting cross-functional collaboration Managing territory budgets, KOL mapping, and CRM entries Attending conferences and engaging with medical societies Requirements: 8+ years as a medical science liaison in eye care Strong emotional intelligence, communication, and presentation skills Ability to work independently, manage priorities, and adapt to a fast-paced environment Experience with Microsoft Office and CRM software Willingness to travel up to 70%, with residence near a major airport on the East Coast #GKOSUS #LI-REMOTE

MAIN JOB RESPONSIBILITIES / COMPETENCIES 1. Act as consolidation point for receiving, processing, investigating and reporting product complaints. 2. Coordinate and/or perform the evaluation, investigation, follow-up and documentation of all STAAR product complaints. Maintain complaint files. 3. Coordinate complaint investigations according to complaint handling procedures, which includes but is not limited to: a. Interface with physicians and/or health care professionals regarding information relevant to the product complaint. b. Interface and coordinate with Regulatory, Quality, Clinical Affairs and Medical Affairs to conduct investigations, risk assessments and determine reporting requirements. 4. Perform prompt handling of complaints, including identification and evaluation of device product complaints for potential reportable adverse event according to procedures. 5. Inform management responsible for complaint handling when information in a complaint suggests that action may be required to prevent unreasonable risk of substantial harm to the public, that there is an indication of a trend or that there are unusual adverse events. 6. Ensure incident reports (e.g. Medical Device Reports, Health Canada Reports, Vigilance reports, etc.) are submitted in compliance with respective regulations (e.g. U.S. FDA Regulations, Canadian Medical Device Regulations, MDD/MDR, MDSAP, etc.) 7. Ensure accuracy, integrity, completeness and consistent content of product complaint reports, investigations, incident reports, in the complaint files and electronic complaint database. 8. Support external (e.g. FDA, DEKRA, etc.) and internal audits as required 9. Provide support, as required for other aspects of the post-market surveillance system (i.e., data analysis of complaint reports, files and adverse event reporting logs). 10. Provide support for medical affairs activities, as requested. 11. Other duties as assigned. REQUIREMENTS EDUCATION & TRAINING * High School graduate or equivalent required. Associate's Degree or higher desired. EXPERIENCE * 1 year's ophthalmic experience, or equivalent combination of education and experience, preferred. * 3 years' experience in FDA regulated industry preferred; experience handling complaints and medical device reporting is highly desirable. * Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device manufacturing, including but not limited to, CFRs, ISO 13485, MDD, CMDR, MDSAP, MDR SKILLS * Proficiency in MS Word and Excel. * Ability to work well within a team and interdepartmentally. * Special competencies: timely and quality decision making; well-developed organizational ability, time management reasoning and problem solving skills. * Good communication skills, written and verbal. Pay range: $25 - $32 per hour - Final compensation/salary will be depend on experience STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.

What You'll Do: This role will be responsible for producing high-quality clinical and clinical regulatory documentation that will require a strong understanding of medical and regulatory concepts and terminology as well as the ability to translate complex information into clear and concise documentation. Will work closely and collaborate with project teams spanning multiple departments on Glaukos's current and pipeline of products. The Sr. Medical Writer will be responsible for engaging with cross-functional stakeholders to extract key information, and synthesize that into a clear, logical presentation. You will ensure that documentation is accurate, complete, meets editorial and client specifications, and adheres to established guidelines and standards. Prepares clinical study reports (CSRs) with limited supervisor direction; based on the clinical study protocol and statistical analysis plan, translates clinical result data tables, listings and figures into a report on the study outcomes, completes final check for discrepancies within data, and ensures compliance with relevant regulatory agencies. Translate clinical study synopsis into full clinical study protocol, ensuring appropriate level of depth and detail, as well as technical accuracy. Works with other members of the project team to obtain input. Interpret data, analyze results, and apply knowledge of regulatory/compliance/scientific requirements to document preparation. Systematically review reports and clinical data and cross-check information Ensure consistency in style, tone, and quality across all documents. Develop and maintain standardized templates and style guides for clinical and regulatory documentation. Conduct medical and scientific literature database research to support documentation efforts. Review, edit, and cross-check documents produced by other team members for clarity, accuracy, and compliance. Stay up-to-date with industry trends, regulatory requirements, and best practices in both technical and medical writing. Develop and maintain lists of abstract deadlines, key dates, and locations for relevant/major ophthalmology conferences. Coordinate with R&D leadership to prepare conference abstract submissions while ensuring compliance with conference rules and company objectives and strategy. Prepare and proof presentations (slide decks and posters) as required for physicians and other key internal stakeholders Develop figures for publications and presentations (peer-reviewed publications, presentations, and posters) to align with company strategy Support phase I through phase IV studies prior to database lock, identifying any adverse events or protocol deviations and works with cross-functional Participate in project meetings and provide updates on the status of writing assignments. How You'll Get There: Bachelor's Degree Required, Master's Degree or PhD Preferred 5-8 years of relevant work experience in a clinical or scientific space Deep understanding of therapeutic areas (ophthalmology), clinical research, and regulatory requirements Fluency in technical and medical terminology Experience in pharmaceutical regulatory submissions Experience with scientific publications and presentations Familiarity with ophthalmic indications and treatments preferred Excellent writing, editing, and proofreading skills Proficiency in using documentation tools and software such as Microsoft Office Suite, Adobe Acrobat, and content management systems (CMS) Strong organizational and project management skills Excellent communication and interpersonal skills #GKOSUS

At Roche, we are committed to delivering greater benefits to our patients. To achieve this, we are seeking a hands-on Operational Excellence expert to drive breakthrough performance improvements and build long-term capabilities. This role is about delivering step-change improvements, not just marginal gains, by embedding structured, data-driven methodologies that enhance efficiency, quality, and overall operational performance. As a member of the Performance Excellence Delivery team within our Pharmaceutical Global Operational Excellence organization, you will work with site teams, integrating traditional Lean principles with cutting-edge digital solutions to drive true transformation. Our Holistic and well-defined Breakthrough Methodology follows four key steps: Diagnose, Design, Implement, and Sustain, ensuring a structured and lasting impact. This is a role for a true impact driver, someone who thrives in hands-on environments, collaborates closely with teams, and is passionate about accelerating performance and creating tangible, sustainable results. The Opportunity On-Site Performance Improvement - Partner with local teams to identify and implement measurable and sustainable operational enhancements Breakthrough Performance Gains - Lead structured initiatives that go beyond incremental changes, driving significant improvements in quality, efficiency, and productivity Sustainable Capability Building - Coach and develop teams to adopt best-in-class methodologies, embedding long-term operational excellence Systematic, Data-Driven Approach - Apply proven frameworks to ensure measurable, repeatable success Leveraging Digital for Operational Improvement - Utilize digital tools and data analytics to accelerate efficiency gains and optimize end-to-end processes Cross-Functional Collaboration and Change Leadership - Engage with all levels of the organization to drive alignment, secure buy-in, and foster a culture of continuous improvement Performance Monitoring & Long-Term Impact - Define and track key performance indicators to ensure initiatives deliver lasting business value, not just short-term fixes. Who You Are Bachelor's degree and a minimum of 8 years of related/relevant experience; or an advanced degree with 6 years of equivalent work experience. Extensive experience in pharmaceutical manufacturing or related field, with a focus on sterile environments (Highly preferred). Proven expertise in Lean methodologies and leading structured performance improvement initiatives. Demonstrated success in delivering transformational impact (step-change improvements), not just incremental changes, in operational environments. Demonstrated ability to synthesize complex information and data sets, extract actionable insights, and craft compelling presentations that drive decisions. Experiences in top consulting firms (Highly preferred). Locations This is a primarily on-site role in Oceanside. Relocation benefits are available for this position. The expected salary range for this position based on the primary location of Oceanside is $120,400 and $224,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

GLAUKOS - SR. INTERNAL AUDITOR (ALISO VIEJO, CA) "We'll Go First" (***************************** *Total Compensation Package includes base, bonus, and RSUs. * #GreatPlaceToWork Benefits include: 401k company match, Trackless PTO, Company Holiday Break, ESPP (Employee Stock Purchase Plan),On-site Gym, Food Truck Fridays, Wellness Wednesdays, Cold Brew/Kombucha on tap, and much more!! How will you make an impact? The Senior Internal Auditor is responsible for performing individual internal audit projects as part of the annual internal audit plan, as well as special audits at the request of Management. This responsibility includes developing internal audit scope, performing internal audit procedures, and preparing internal audit reports reflecting the results of the work performed. The Sr. Internal Auditor works under the direction of and in collaboration with their manager; however, it is expected they can execute assignments (audits, investigations, and special projects) with little to no instruction; using logic and reasoning to determine the scope and approach for those assignments. This role will manage tasks and processes to completion. This position involves individual, independent assignments as well as projects supported by more than one auditor. The role requires the ability to take the lead in some cases and at other times be an effective team member in a support capacity. Assignments are based on skill, experience, and professional development of learning opportunities. What will you do? Conduct audits of assigned organizational and functional systems and processes in accordance with the annual internal audit plan and perform special audits at the request of Management. Plan and execute audits in accordance with internal auditing standards. Lead and support walkthroughs and testing of Internal Controls over Financial Reporting (SOX). Evaluate the adequacy, effectiveness, and efficiency of management's controls over audited activities. Prepare work papers to ensure compliance with established Internal Audit Standards. Report audit findings and provide value added recommendations to enhance the Company's internal controls and operating efficiencies, and other processes necessary to mitigate the Company's risks. Periodically perform follow-up reviews to ensure planned corrective actions are implemented and items are closed. Develop effective business relationships within the organization to support internal audit initiatives. Stay informed of best practices both internally and externally and be a conduit for introducing those practices to the Company. How will you get here? A minimum of 3-5 years of internal/external audit or industry experience. Bachelor's degree in Accounting, Finance, Business Administration or related discipline from an accredited college or university. MBA, CPA, CIA, CISA, CMA are a plus. Strong knowledge of the Sarbanes-Oxley Act, specifically sections 302, 404, etc., with hands-on experience with SOX implementations and ongoing compliance in industry. Knowledge of US GAAP, PCAOB Audit Standards and the Standards for the Professional Practice of Internal Auditing and the Code of Ethics developed by The Institute of Internal Auditors (IIA). Understanding of internal control concepts and frameworks (e.g. COSO). Good interpersonal skills and the ability to communicate effectively, verbally and in writing, at all levels of management. Proficient in MS Office suite, electronic audit work paper and audit analytical tools. Experience with complex ERP systems (e.g. Oracle, SAP etc.) Strong oral and written communication skills Effective time management, change management, organizational skills and strategies *Willingness and ability to travel up to 25% - both domestically and internationally #GKOSUS

GLAUKOS GMP MAINTENANCE TECHNICIAN III (San Clemente, CA) How will you make an impact? The Maintenance Technician III is responsible for the maintenance, repair, and optimization of various building systems and production equipment to ensure the efficient operations in a cGMP (Current Good Manufacturing Practices) environment. Key responsibilities include coordinating maintenance schedules, conducting equipment preventative and corrective maintenance and inspections, troubleshooting equipment malfunctions, and implementing preventive measures to ensure compliance with safety regulations and enhance operational efficiency in support of production, office, laboratory, and cleanroom spaces. The ideal candidate will possess experience in GMP equipment, HVAC, electrical, plumbing, and mechanical systems, along with strong communication, and problem-solving skills to effectively manage the facilities and support the organization's production team objectives. What will you do? Essential Duties: Perform routine and preventive maintenance activities on cleanrooms, manufacturing equipment, purified water systems, laboratory instruments, laboratory refrigerators, freezers environmental chambers, HVAC systems, utilities, and other facility assets according to established schedules and procedures in adherence to cGMP standards. Conducts inspections, diagnostics, and troubleshooting to identify and resolve equipment malfunctions, mechanical issues, or electrical failures promptly and effectively. Maintain accurate records of maintenance activities, including work orders, equipment histories, and calibration data, to support regulatory audits and quality assurance requirements. Monitors and documents the operation and maintenance of all HVAC-related equipment and systems. Assist in the installation, commissioning, and qualification of new equipment and facility upgrades, ensuring compliance with cGMP standards and technical specifications. Maintains and repairs a wide variety of air conditioning and heating systems, from mini-split systems to chillers, pumps, air handling units, fan coils, exhaust fans, dampers, ducts, piping, thermostats, controls, HVAC water treatment and all other conditioned air system components. Develops and assists in maintenance of other systems such as humidification systems, water systems, compressed dry air systems, vacuum systems, and other similar critical systems. Comply with departmental policy for the safe storage, usage, and disposal of hazardous materials. Maintain a clean and safe work environment. Support in overseeing the activities of contractors associated with production equipment operations. Assist with safety inspections and see that all facility safety issues are corrected. Documents all GMP work in the Computerized Maintenance Management System (CMMS). Maintain records and prepare reports. Establish and maintain cooperative working relationships. Understand and carry out oral and written directions. Work successfully in a multicultural environment. Work independently with little or no supervision. Maintain preventive maintenance programs. Support off-shift hours and weekends if necessary. Perform other related duties as assigned. How will you get here? Requires a minimum of 4-6 years of related experience, or an AA with 2-4 years of experience, or a Bachelor's degree with 0-2 years of experience. High school diploma or GED required. Facilities experience in critical environments such as clean rooms and or within the life sciences industry. Position requires knowledge of: Requires knowledge of working in cleanroom environments. Troubleshooting and service of electrical and plumbing systems. GMP equipment service. Computerized maintenance management systems. Package units, heat pumps, pumps and water treatment systems. Heat recovery and energy storage systems. Basic desktop computing. Building Management Systems. #GKOSUS

How will you make an impact? This microbiologist role will have a strong background in performing method development, method validation, method transfer activities as well as routine testing of raw materials, in-process testing and finished product. This exciting role will support microbiological activities for the Glaukos organization, which includes R&D as well as commercial manufacturing. The candidate must have experience in cGMPs, regulatory body requirements and FDA compliance and must be proficient in microbiological testing per USP/EP/JP. The candidate must have an understanding of aseptic processes and manufacturing. What You'll Do: Develop and implement microbiological strategies and procedures to ensure compliance with industry standards and regulations Perform method development, feasibility and validation of raw materials, in-process and final product. Conduct routine microbiological testing and analysis of samples, ensuring accuracy and reliability of results. Perform routine and stability testing of GLP and GMP supplies Write and revise SOP's, validation protocols/reports Perform testing as needed to generate data for validation and special projects. Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ) Maintain accurate and up-to-date documentation of all microbiological activities, including test results, procedures, and reports Review and interpret test results, prepare reports, and communicate findings to relevant stakeholders Identify and implement improvements to existing microbiological processes, methods, and techniques to enhance efficiency and productivity Collaborate with cross-functional teams, such as quality assurance, research and development, and production, to support product development and continuous improvement initiatives Stay updated with the latest advancements and trends in the field of microbiology and recommend and implement new technologies and methodologies as appropriate Ensure compliance with relevant regulatory requirements and standards, such as Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), and ISO standards How will you get here? Bachelor's degree in Microbiology, Biology or related scientific field Minimum 8 years of related pharmaceutical experience in a cGMP environment Proficiency in microbiological techniques such as aseptic testing, microbial monitoring, gram staining, and plating Proficiency in testing according to AAMI/ISO/USP Standards Knowledge and control of laboratory equipment including calibration and maintenance Ability to understand and perform all required tasks by adhering to company Standard Operating Procedures and all current Good Manufacturing Practices Understanding of quality systems including change control, deviations and CAPAs; support investigations as needed Ability to handle multiple tasks concurrently and complete tasks in a timely manner Strong written and verbal language skills to effectively read and write SOP's and related labreports and effective communication skills to present data with personnel at all levels in the organization Excellent teamwork skills, organizational skills, and strong attention to detail Knowledgeable in regulatory requirements and industry standards related to microbiology Proficient in using microbiological testing equipment and software; Knowledge and proficiency in computer software (e.g. Microsoft Office programs) Attention to detail and high level of accuracy in performing microbiological tests and analysis and excellent analytical and problem-solving abilities to interpret test results, troubleshoot issues, and recommend solutions Ability to work collaboratively in cross-functional teams and adapt to changing priorities and deadlines Strong organizational and time management skills to prioritize tasks and meet project timelines Ability to lift 25 lbs. Ability to stand or sit 8 or more hours a day Work in a sterile environment wearing appropriate gowning and protective equipment #GKOSUS

Glaukos - Manager, Compliance (Aliso Viejo, CA) The Manager of Compliance will play a pivotal role in strengthening our enterprise healthcare compliance program and driving a culture rooted in ethics, transparency, and trust. This role ensures adherence to all applicable laws, regulations, and industry standards - including the Anti-Kickback Statute, False Claims Act, HIPAA, and Sunshine Law - while partnering across the business to support responsible growth and decision-making. You'll be a key strategic partner, helping to build scalable processes, promote awareness, and enable teams to do what's right for patients, customers, and the business. What You'll Do Compliance Process Management Develop and implement effective compliance policies, procedures, training programs, and employee communications Lead state-required compliance program audits and proactively monitor changes in state and federal laws Support the development and execution of the annual auditing and monitoring plan and ensure timely remediation Cross-Functional Partnership Collaborate closely with internal stakeholders across Marketing, Sales, IT, Quality, Medical Affairs, Finance, Clinical Research, and Commercial Services to align priorities and deliver results Drive operational efficiency by optimizing workflows, identifying bottlenecks, and ensuring teams are equipped for success Continuous Improvement Manage key compliance projects, tracking milestones, documentation, training, and reporting deliverables Develop actionable metrics and leverage insights to identify trends, emerging risks, and opportunities to elevate program effectiveness What You'll Bring 8+ years of relevant experience in pharmaceuticals, medical devices, or diagnostics 2+ years in a regulated environment with demonstrated understanding of healthcare compliance frameworks Strong cross-functional project management experience and ability to navigate complex organizations Proficiency with analytics tools (e.g., Tableau) and CRM/ERP systems (e.g., Salesforce, Veeva, SAP); advanced Excel skills A proactive mindset with strong business acumen, sound judgment, and attention to detail Excellent collaboration, communication, and problem-solving skills Bachelor's degree required; CCEP or CHC certification preferred #GKOSUS

Senior Manager, Facilities Engineering (San Clemente, CA) Are you ready to lead innovation and drive excellence in facilities engineering? Join our team as a Senior Manager of Facilities Engineering and play a pivotal role in shaping the future of our building operations. We're looking for a strategic leader who thrives on technical challenges, inspires high-performing teams, and is passionate about sustainability and continuous improvement. What You'll Do Lead and Inspire * Guide and develop a talented team of facilities engineers, fostering a culture of safety, accountability, and growth. * Set clear goals, provide coaching and mentorship, and manage staffing plans to ensure team success. * Champion project management and process standardization across multiple sites. Drive Operational Excellence * Oversee the daily operation and maintenance of all building systems, including HVAC, electrical, plumbing, fire/life safety, controls, and critical infrastructure. * Ensure compliance with all regulatory, environmental, safety, and building codes (OSHA, NFPA, ASHRAE, and local jurisdictions). * Implement preventive and predictive maintenance programs to maximize equipment uptime. Shape Engineering Strategy * Develop and execute long-term engineering strategies aligned with organizational goals. * Lead root cause analysis for system failures and implement corrective and preventive actions. * Optimize building and utility system performance through data-driven analysis and best practices. Lead Capital Projects * Plan, budget, and execute capital improvement projects, system upgrades, and infrastructure expansions. * Manage design reviews, engineering specifications, vendor selection, and contractor oversight. * Ensure projects meet technical, financial, and schedule objectives. Manage Budgets and Vendors * Oversee facilities engineering budgets, including CapEx and OpEx planning. * Negotiate vendor contracts, manage service agreements, and ensure high-quality service delivery. * Track and report key performance metrics, spending, and resource utilization. Champion Safety, Compliance, and Sustainability * Ensure all facility operations adhere to safety and compliance standards. * Drive energy efficiency, sustainability initiatives, and waste reduction efforts. * Maintain documentation for audits, inspections, and regulatory reporting. What You'll Bring * Bachelor's degree in Mechanical, Electrical, Facilities Engineering, or a related field (Master's preferred). * 9+ years of experience in facilities engineering or management, with at least 3-5 years in a leadership role. * Experience in the medical device industry is a plus. * Strong knowledge of building automation systems, mechanical/electrical systems, and utility infrastructure. * Proficiency in CMMS platforms, engineering documentation, and system design principles. * Deep understanding of safety regulations, energy codes, and environmental compliance. * Exceptional leadership, stakeholder management, and communication skills. * Ability to manage multiple projects, prioritize effectively, and solve complex problems. * Strategic thinker with a strong track record of operational execution. #GKOSUS

The Senior Product Surveillance Specialist II serves as a key leader within the global Post-Market Surveillance (PMS) program at Glaukos, ensuring compliance with worldwide medical device and pharmaceutical regulations. This individual will independently lead global surveillance activities, monitor product performance, identify safety trends, and ensure timely and accurate regulatory reporting across multiple markets. Key Responsibilities Lead global PMS activities, including annual reviews and preparation of PMSRs, PSURs, Trend Reports, and related regulatory submissions. Oversee global Medical Device and Vigilance reporting to ensure compliance with FDA, EU MDR, Health Canada, and other international standards. Collaborate cross-functionally with Regulatory, Quality, and Medical Safety teams to ensure comprehensive reporting and inspection readiness. Analyze complaint and field data to identify trends and recommend risk mitigation actions. Maintain and update PMS procedures to align with evolving global regulations and best practices. Provide guidance and mentorship to junior team members while operating as an independent subject matter expert. Qualifications Bachelor's degree in life sciences, engineering, pharmacy, or related field; advanced degree preferred. 8+ years of experience in post-market surveillance, regulatory, or quality within medical device or pharma. Strong working knowledge of EU MDR, FDA 21 CFR Part 803, ISO 13485, and ICH guidelines. Proven experience preparing PMSRs/PSURs and managing global vigilance reporting. Excellent analytical, communication, and organizational skills. Experience supporting regulatory inspections and audits. Familiarity with electronic complaint handling and reporting systems. #GKOSUS

What You'll Do: The Statistical Programmer II will work onsite in our corporate headquarters in Aliso Viejo, CA. The Statistical Programmer II generates datasets, tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications. This position requires a basic understanding and ability to provide datasets using current industry standards including Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with Statisticians and other clinical team members to ensure programming requirements are understood. i.e. Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production. i.e. Following the SDTM Implementation Guide and written specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets. Generate tables, figures, and listings, (TFLs) in accordance with the SAP and TFL shells to support analyses using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology. Assist in validating SAS programs, macros, datasets, and TFL output generated by other Programmers. Other duties as assigned How You'll Get There: 3+ years of experience required with BA/BS Degree, 2+ years of experience with Master's Degree High proficiency in SAS programming Experience working with CDISC SDTM and/or ADaM compliant data sets Knowledge of statistics and the drug development process Knowledge of FDA/ICH guidelines and industry/technology standard practices Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs Solid verbal and written communication skills Bachelor's /Master's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required; Master's degree is preferred. Great compensation and benefits! This is not a remote role and we are willing to assist with relocation! #GKOSUS

GLAUKOS - INTERVENTIONAL GLAUCOMA BUSINESS MANAGER (Montgomery, AL) *Total Targeted Compensation $220-250K+ How will you make an impact? The Interventional Glaucoma Business Manager (IGBM) plays a critical role in driving the adoption and integration of Glaukos technologies within ophthalmic surgical practices. This individual will achieve quarterly sales objectives by engaging targeted ophthalmic surgeons, providing clinical support during procedures, and delivering hands-on training to ensure optimal patient outcomes. The IGBM manages the territory strategically, focusing on customer success, business growth, and long-term partnership development. What will you do? Sales Strategy & Execution Achieve monthly, quarterly, and annual sales targets across multiple product lines. Develop and execute territory business plans to maximize revenue and market penetration. Identify and cultivate new business opportunities while maintaining and expanding existing accounts. Leverage data and insights to drive adoption and deliver consistent growth. Clinical Integration & Support Conduct surgical wet labs and in-service training to support surgeon onboarding and skill development. Attend initial procedures to ensure surgeon proficiency with Glaukos technologies. Provide ongoing clinical support and share best practices to improve outcomes and satisfaction. Collaborate with surgeons on patient selection and procedural success. Customer Engagement & Education Build strong relationships with key stakeholders at ASCs, hospitals, and private practices. Train staff and physicians on patient identification and conversion to Glaukos technologies. Serve as a trusted resource for clinical and product education. Develop Key Opinion Leaders (KOLs) and product champions to drive peer influence. Market Development & Events Represent Glaukos at targeted industry meetings, conferences, and educational programs. Organize local events and peer-to-peer programs to strengthen surgeon engagement. Monitor competitive activity and market trends to inform strategy and protect market share. How will you get here? Minimum 5 years of medical sales experience, including at least 3 years in surgical ophthalmology. Ophthalmic pharmaceutical experience (4+ years) strongly preferred. Proven track record of exceeding sales targets and driving territory growth. Experience with new product launches and expanding territories. Demonstrated success in building and maintaining strong customer relationships. Proficiency in Salesforce CRM and Microsoft Office (PowerPoint, Excel, Word, Outlook). Excellent communication, presentation, and organizational skills. Strong problem-solving ability and a passion for customer success. Must demonstrate professionalism, integrity, and adherence to compliance and administrative standards. #GKOSUS #LI-Remote

Performs a variety of manufacturing engineering activities on ocular related products including manufacturing scale up, development, and sustaining activities. Responsibilities include developing creative solutions to manufacturing problems, development and execution of process, equipment, and product validations, ensuring the proper engineering deliverables are accurately generated, generation of 3D CAD models and 2D CAD drawings for assembly tools and fixtures, test procedures, project management and leadership, and maintaining schedule. May lead manufacturing related project teams with other engineers, technicians, and manufacturing staff with a focus on meeting manufacturing requirements with technically strong, high quality, cost effective approaches. Duties shall be performed with attention to detail while supporting Glaukos' Quality Policy and the appropriate regulatory agencies, including FDA Quality System Regulations (21 CFR 820), 21 CFR 210/211 and ISO Standards (ISO 13485). Develop and Improve Manufacturing Methods and Processes * Develop and improve manufacturing methods, systems, and processes to produce high quality products that are complex and broad in scope at optimal cost. * Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. Provide manufacturing input during design review meetings. * Provide engineering support to the manufacturing operation on routine basis. Address product and process related issues arising on the production floor including proactively identifying and solving known issues to improve yields and cost. * Identify and evaluate opportunities for improvement and make specific recommendations for adoption. Perform cost analyses to reduce or optimize product costs. * Write process protocols, reports, manufacturing instructions, procedures, and FMEA. * Ensures compliance with GMP's and internal protocol. Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations. * Utilize establish ERP system to support manufacturing operations. * Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. Collaborate on design with suppliers to fulfill equipment and fixturing requirements. Establish and manage preventive maintenance program. * Design and/or provide oversight for processes, fixtures, and tooling for associated manufacturing operations. * Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Applies six sigma methodology as appropriate. How You'll Get There: Experience: * BS Mechanical Engineering or equivalent required * 2+ years related experience, or a Master's Degree and a minimum of 0-2 years of experience * 2+ years of medical device or pharmaceutical experience. * Experience with ocular product a plus * Detail oriented with the ability to work in a clean room environment. * Experience with phased new product development processes from concept through full production release. * Ability to work in team environment as contributor and leader * Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management. * Excellent decision making/problem solving skills. * Strong verbal and written communication skills. * Proficient in MS Word, Excel, Statistical Software, Outlook, and MS Power Point. * Ability to use MS Project (Only for level Sr and Principal). * 2+ years or experience working as manufacturing engineering on complex medical device / pharma subassembly and top-level assembly builds. * 2+ years of experience working with a wide range of manufacturing methods, including machined, extruded, molded and laser cut parts. * 2+ years' experience generating tooling / fixturing design to support production, Solidworks design preferred. * Knowledge of cGMP and ISO regulations required. * Experience with MRP a plus. * Ability to interact with all departments required. * Ability to coordinate activities with outside vendors. #GKOSUS

How you will make an impact: The Clinical Trials Associate II is responsible for the coordination of clinical research studies in compliance with U.S. and international regulations under the guidance of a Clinical Manager or Clinical Director. What you will you: Clinical Study Preparation and Maintenance Assists with review of clinical trial protocols Assists with development/review of source documents Assists with preparation of Informed Consent Forms Assists with development of recruitment materials and study tools Works with cross functional team members as assigned Works with study vendors as assigned Collection and Review of Site Start-Up Documents Communicates directly with site staff to obtain site start-up documents Negotiates study contract and budget Prepares Regulatory Binders and provides to sites prior to Site Initiation Visit (SIV) Receives, QC's, and files site documents in Study Master File Provides status of site documents in Study Master File to Clinical Research Associates (CRAs) prior to Monitoring Visits Clinical Site Management CTA is responsible for effective communication with clinical trial sites Obtains site documents from Clinical Research Associates during trial Addresses inquiries from sites and CRAs Escalates issues to study management as needed Study Master File Maintenance Sets up Study Master File and Study Master File Tracker at the beginning of each study Receives, QC's, scans and files documents in Study Master File Provides status of documents to Clinical Management Establishes and Maintains Tracking of Trial Information Team and site contact information Site status information Equipment and supplies Enrollment trackers Adverse event trackers Site payment trackers and site payments How You'll Get There: Bachelor's Degree with background in science, or equivalent work experience preferred 2-5 years clinical work experience in the bio- pharmaceutical or device industry, preferably within the ophthalmology field #GKOSUS