Regulatory affairs specialist job description

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.
Owens & Minor teammate benefits include:

Medical, dental, and vision insurance, available on first working day 401(k), eligibility after 30 days of employment Employee stock purchase plan Tuition reimbursement Development opportunities to grow your career with a global company



Job Summary


This will be a remote position. The Regulatory Affairs Specialist II provides leadership in the development and implementation of regulatory strategies to support the achievement of business objectives while coordinating activities with internal team members and external parties such as regulatory bodies, regulatory consultants and the like to obtain and maintain regulatory filings, registrations and compliance. The Regulatory Affairs Specialist II reports to the Associate Director of Regulatory Affairs. The individual is responsible for monitoring design, documentation, and change control processes to assure policies, procedures and practices are in compliance with appropriate regulatory requirements. This individual provides analytical, interpretive and evaliuatiive solutions to complex problems through specialised regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinate activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority. position is responsible for directing and coordinating activities necessary to ensure global regulatory compliance with FDA, Canadian, European and other agency regulations. This position will manage division regulatory activities and serve as the direct liaison with regulatory agencies, as well as with other internal functional departments for new product development strategy. This position also oversees existing division products and obtains marketing approval for new/modified device applications.


Core Responsibilities


Assists the research and development team during new products development as well as assists in design control processes Provides global regulatory assessment and pathway(s) Obtains regulatory verification and confirms global strategy for new product development Determine regulatory filing strategies and submission types Develops, submits and coordinates with internal partners for filings of 510(k), IDE, PMA, ANDA, NDA, Technical Files and Design Dossiers for regulatory approval and clearance world wide Reviews and makes final determinations for regulatory assessments of proposed changes to existing products Reads, reviews, interprets and keeps current with regulations and publications regarding device and PPE products with primary focus on medical devices Manages necessary corrective action in all areas of responsibility which leads to improved product quality, process efficiency, minimum corporate exposure, and maximum profitability Ensures that all necessary quality assurance, regulatory and validation procedures and policies are in place and up to date Manages company regulation and documentation programs including development and distribution of standard operating procedures (SOPs), policies, and technical reports Directs and reviews company self-audit and corrective action programs to ensure compliance with Good Manufacturing Practices (GMPs) and Medical Device amendments Maintains appropriate relationships with foreign and domestic regulatory governmental agencies by serving as a liaison Active participation and support for all continuous improvement and SOP efforts which leads to increased productivity, profitability, and customer satisfaction in areas of responsibility Provides technical assistance and consultation to marketing, manufacturing, and customers regarding raw material selection, competitor product evaluation, and troubleshooting Reviews and approves promotional materials for use in markets of responsibility Provides assistance to contracts and sales with regards to product registration status and product characteristics needs for contracts



Qualifying Experience


Bachelor's degree in biological sciences, microbiology chemistry or engineering required; Graduate studies in Regulatory Affairs preferred RAC certified professional and project management skills desirable 5+ years experience in Regulatory Affairs in a medical device company Experience in dealing with FDA, Notified Bodies and other regulatory agencies Working knowledge of ISO and applicable International regulations, compliance and audit practices Intermediate level proficiency in Microsoft Office programs (Excel, PowerPoint, Word) Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision 25% domestic travel


We also invite you to connect with the Recruiter via LinkedIn. #LI-TP1

If you feel this opportunity could be the next step in your career, we encourage you to apply.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

**What Regulatory Affairs contributes to Cardinal Health**

Regulatoryprovides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals\. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting\.

Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval\. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions\.

_Accountabilities_

+ Research, analyze and explain regulations, policies, or procedures
+ Maintain data in information systems or databases
+ Ensure compliance with regulations
+ Advise others on regulatory and compliance matters
+ Evaluate applicable laws and regulations to determine impact on company activities
+ Provide technical review of data or reports
+ Coordinate regulatory documentation and submissions activities
+ Assist in obtaining and maintaining government approvals for medical devices
+ Identify and interpret relevant regulatory guidelines

**Qualifications**

+ Bachelors in related field, or equivalent work experience, preferred
+ 4\+ years experience in related field, preferred

**What is expected of you and others at this level**

+ Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
+ May contribute to the development of policies and procedures
+ Works on complex projects of large scope
+ Develops technical solutions to a wide range of difficult problems\. Solutions are innovative and consistent with organization objectives
+ Completes work independently receives general guidance on new projects
+ Work reviewed for purpose of meeting objectives
+ May act as a mentor to less experienced colleagues

Anticipated salary range: $72,000 \- $105,000

Bonus eligible: No

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

\#LI\-remote

_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background\. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day\. Cardinal Health is an Equal Opportunity/Affirmative Action employer\. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law\._

_To read and review this privacy notice click_ here \(https://www\.cardinalhealth\.com/content/dam/corp/email/documents/corp/cardinal\-health\-online\-application\-privacy\-policy\.pdf\)

Cardinal Health is an Equal Opportunity/Affirmative Action employer\. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status\.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
• Leads or compiles all materials required in submissions, license renewal, and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking/control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for the earliest possible approvals of clinical trial applications.

Must Have (Minimum Requirements):

• Bachelor's degree required with a minimum of 2 years of regulatory affairs related experience
• OR an advanced degree with 0 years of regulatory affairs experience

Nice to Have (Preferred Qualifications):

• Degree in a scientific discipline (engineering, physical/biological or health sciences).
• 2+ years of experience in regulatory affairs
• Effective interpersonal skills.
• Effective team member.
• Ability to comprehend principles of engineering, physiology and medical device use.
• Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient computer skills.
• Experience with 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances.
• Experience with FDA and international regulatory agency requirements
• Project management skills.
• Excellent oral and written skills.

About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.


Physical Job Requirements


The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)