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Become A Regulatory Affairs Specialist

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Working As A Regulatory Affairs Specialist

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Updating and Using Relevant Knowledge
  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Mostly Sitting

  • $70,886

    Average Salary

What Does A Regulatory Affairs Specialist Do At Kelly Services

* This position will work with software medical device products including both stand-alone software SaMD and embedded software SiMD.
* Expert in regulations in order to author entire Regulatory dossiers and identify and suggest potential strategies that can be used to address the gaps Identifies and defines contents for Regulatory submissions/dossiers.
* Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
* Provides Regulatory support to life cycle project teams at any point in the development process Interacts with and/or directs others in interacting with Regulatory and Certification authorities Identifies the need for, prepares, and conducts Regulatory related training for the business Represents functional area within specific business area to provide guidance and recommendations for issues that may arise.
* May require approvals from management.
* Assumes major responsibility for one or more major Regulatory Affairs areas based on past experience and a broad base of knowledge and understanding of regulatory requirements Identify problems and significantly improve, change or adapt existing methods and techniques drawing from personal experiences and feedback Reviews device labeling , advertising materials and product manufacturing changes for compliance with global regulations; analyses and recommends appropriate changes Advises business management of regulatory and certification issues in a pro-active manner Exercises considerable judgment in determining approach and then researches, prepares, and submits required regulatory documents including those in response to documents issued by regulatory authorities.
* Responsibility includes both preparation of these documents in compliance with U
* S. and international regulatory authorities and providing guidance to Regulatory staff in the preparation of them.
* Reviews submissions to identify adequacy of sections, overall content of submissions and completeness of submission and consistency of story Collaborates with individuals at different levels and develops, or is responsible for the development of either solutions to problems of limited complexity that affect diverse functional areas, or solutions to problems of moderate complexity that may affect a few functional areas Executes policies at direction of supervisor and makes recommendations for improvements within the organization

What Does A Regulatory Affairs Specialist Do At Stryker

* Prepare and/or support worldwide submissions for new products and product changes as required to ensure timely approval for market release.
* Review significant regulatory issues with manager/VP as necessary and negotiate submission issues directly with agency personnel.
* Work integrally with new product development and clinical research teams to provide support, guidance and planning to secure approvals for clinical investigations.
* Plan, coordinate and prepare document packages for regulatory submissions, including Class II and III U
* S. FDA Pre
* Market Approval (PMA), Pre
* Market Notification (510(k)), Investigational Device Exemption (IDE), Design Dossiers, Shonins, Canadian Device License Applications, and internal “Letters to File.”
* Support ongoing regulatory compliance activities to include regulatory assessment of product design or process change, preparation of annual reports, required PMA supplements, establishment license, and device listing renewals.
* Negotiate directly with the FDA and other worldwide agencies on applicable products/projects.
* Develop and implement global regulatory strategies for new and modified products.
* Maintain submission correspondence files and other regulatory files in a complete and secure manner.
* Create project deliverables, aligned with appropriate internal and external guidance documents.
* Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
* Review and sign-off on product, supplier, and manufacturing changes for compliance with applicable regulations.
* Support highly technical or major business segment products lines, special projects or strategic initiatives.
* Provide regulatory input in quality system assessments.
* Research new FDA and worldwide regulatory decisions or rulings and how they may affect the company's activities.
* Conduct corporate training in GMP and other regulations.
* Support various internal compliance audits.
* May have responsibilities directing daily activities of and mentoring less-senior members of Regulatory Affairs team.
* Track and report worldwide registration status.
* Implement process improvement projects within Regulatory Affairs.
* Perform other related duties as assigned.
* Minimum Qualifications

What Does A Regulatory Affairs Specialist Do At Thermo Fisher Scientific

* Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.
* Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues.
* Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews, timeline development/reviews, and V & V reviews.
* Develops the regulatory strategy for project team(s).
* Applies advanced regulatory expertise to the evaluation and solution of submission problems.
* Actively reviews and edits documents associated with product development meetings.
* Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
* Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.
* Responsible for vigilance activities, including filing and monitoring recalls/corrections/FSCA, incidents, and MDR’s.
* Review and interpret scientific literature and summarize effectively in writing.
* Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.
* Ensure training and compliance with global quality system regulations.
* Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date.
* Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
* Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
* Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing
* Contacts and Relations:
* Regular contact and interaction with all levels of the organization
* Daily interaction will occur with technical product owners
* Accountability:
* All Regulatory personnel are expected to maintain the confidentiality of sensitive laboratory information including testing data
* Maintain a cooperative and professional relationship with other laboratory staff and departments

What Does A Regulatory Affairs Specialist Do At BD (Becton, Dickinson and Company)

* The Regulatory Affairs Specialist is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.
* Essential job Functions:
* Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
* Prepare 510(k)s, IDEs, PMA and/or international submissions as required
* Assist in technical interface with FDA and international reviewers and respond to questions
* Provide the appropriate information to support international product registrations
* Provide timely review of product labeling and marketing claim for regulatory compliance; approve as directed
* Provide support required for CE marking activities, including preparation and maintenance of product technical files
* May provide direction of other personnel to accomplish duties

What Does A Regulatory Affairs Specialist Do At Danaher Corporation

* Plans and prepares EPA and regulatory submission documents for US or OUS regulatory filings under minimal supervision.
* Prepares documentation that is complete, accurate, and on time.
* Utilizing detailed, in-depth understanding of EPA and regulations, interprets regulations, and provides regulatory guidance to product development teams.
* Assist in the development of RA strategy for new products and design changes - ensuring EPA and regulatory requirements for target markets are met.
* Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
* Assist in maintenance of technical files, MDD certifications and declarations of conformity in support of EU product registrations/CE mark.
* Participates/ leads product recalls/field actions, including regulatory reporting per required timelines.
* Participates in audits and inspections of the company and its quality systems.
* Qualification

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Regulatory Affairs Specialist jobs

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Regulatory Affairs Specialist Career Paths

Regulatory Affairs Specialist
Senior Specialist Quality Assurance Analyst Senior Quality Assurance
Associate Director, Quality Assurance
13 Yearsyrs
Clinical Research Associate Senior Clinical Research Associate
Clinical Project Manager
10 Yearsyrs
Specialist Licensed Practical Nurse Clinical Research Coordinator
Clinical Research Manager
9 Yearsyrs
Compliance Analyst Regulatory Compliance Specialist Clinical Research Associate
Clinical Study Manager
8 Yearsyrs
Clinical Research Associate Clinical Research Coordinator Senior Clinical Research Associate
Clinical Trial Manager
10 Yearsyrs
Compliance Officer Safety Specialist Clinical Associate
Clinical Trials Specialist
8 Yearsyrs
Project Coordinator Assistant Director Nursing Director
Director Of Clinical Operations
13 Yearsyrs
Quality Assurance Quality Assurance Lead Quality Assurance Manager
Director Of Quality
14 Yearsyrs
Quality Engineer Quality Manager
Director Of Quality Management
13 Yearsyrs
Project Manager Consultant Senior Software Engineer
Engineering Manager
10 Yearsyrs
Compliance Specialist Senior Consultant Operations Director
Executive Director Of Operations
8 Yearsyrs
Project Manager Program Manager General Manager
President Of Operations
11 Yearsyrs
Regulatory Affairs Manager Quality Assurance
Quality Assurance Manager
9 Yearsyrs
Quality Assurance Quality Assurance Manager
Quality Manager
11 Yearsyrs
Quality Engineer Quality Assurance Manager Regulatory Affairs Manager
Regulatory Affairs Director
12 Yearsyrs
Regulatory Affairs Manager
9 Yearsyrs
Specialist Phlebotomist Clinical Research Coordinator
Senior Clinical Research Associate
10 Yearsyrs
Project Coordinator Business Analyst Quality Assurance Manager
Senior Quality Assurance Manager
11 Yearsyrs
Compliance Specialist Business Analyst Quality Assurance Manager
Vice-President Of Quality
15 Yearsyrs
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Regulatory Affairs Specialist Demographics

Gender

  • Female

    63.6%
  • Male

    33.7%
  • Unknown

    2.7%

Ethnicity

  • White

    75.0%
  • Asian

    11.2%
  • Hispanic or Latino

    10.8%
  • Unknown

    2.2%
  • Black or African American

    0.8%
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Languages Spoken

  • Spanish

    43.3%
  • French

    12.0%
  • Japanese

    5.3%
  • Chinese

    4.7%
  • German

    4.7%
  • Mandarin

    3.3%
  • Russian

    3.3%
  • Portuguese

    3.3%
  • Arabic

    3.3%
  • Hindi

    2.7%
  • Italian

    2.7%
  • Polish

    2.0%
  • Turkish

    1.3%
  • Gujarati

    1.3%
  • Vietnamese

    1.3%
  • Cantonese

    1.3%
  • Carrier

    1.3%
  • Urdu

    1.3%
  • Swedish

    0.7%
  • Dutch

    0.7%
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Regulatory Affairs Specialist

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Regulatory Affairs Specialist Education

Regulatory Affairs Specialist

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Real Regulatory Affairs Specialist Salaries

Job Title Company Location Start Date Salary
Regulatory Affairs Specialist, Americas & Asia Emeter Corporation Foster City, CA Sep 27, 2016 $175,000
AD, Regulatory Affairs Biogen, Inc. Cambridge, MA Aug 20, 2016 $159,000 -
$162,000
Regulatory Affairs Specialist Kelly Services, Inc. Raynham, MA Jan 08, 2016 $158,612
AD, Regulatory Affairs Biogen, Inc. Cambridge, MA Sep 08, 2016 $155,000 -
$158,000
Senior Quality and Regulatory Affairs Specialist Medidata Solutions, Inc. New York, NY Sep 14, 2015 $125,000
Staff, Regulatory Affairs Beckman Coulter, Inc. CA Dec 31, 2015 $125,000
Senior Regulatory Affairs Specialist St. Jude Medical, Inc. Selma, CA Oct 26, 2015 $120,000
Senior Regulatory Affairs Specialist St. Jude Medical Cardiology Division Selma, CA Mar 10, 2016 $120,000
Regulatory Affairs Specialist Leading Pharma LLC Fairfield, NJ Apr 10, 2016 $115,000
Regulatory Affairs Specialist Bayer Cropscience Parkton, NC Mar 11, 2015 $110,313
Senior Regulatory Affairs Specialist Abbott Laboratories Milpitas, CA Nov 18, 2016 $109,250
SR. Regulatory Affairs Specialist (Sterile Injectables) Anika Therapeutics, Inc. Bedford, MA Aug 14, 2015 $108,000
GPV Alliance Management & Regulatory Affairs Specialist/Expert Bayer Healthcare Pharmaceuticals Morristown, NJ Nov 29, 2016 $105,368
Staff Regulatory Affairs Specialist Stryker Medical, A Division of Stryker Corporation Portage, MI Sep 06, 2016 $79,741
Staff Regulatory Affairs Specialist Stryker Medical, A Division of Stryker Corporation Portage, MI Sep 03, 2015 $79,741
Regulatory Affairs Operations Specialist, Submissions Merrimack Pharmaceuticals, Inc. Cambridge, MA Sep 16, 2015 $79,439
Regulatory Affairs Integrated Resources, Inc. Lexington, MA Aug 18, 2016 $79,306
Regulatory Affairs Scientist Mars Petcare Us, Inc. Franklin, TN Apr 03, 2016 $79,000 -
$118,400
Safety Data/Regulatory Affairs Specialist The Fountain Group LLC Morristown, NJ Jul 09, 2015 $78,596
Regulatory Affairs Specialist I Boston Scientific Corporation Maple Grove, MN Aug 09, 2016 $65,598
Senior Regulatory Affairs Specialist Cognizant Technology Solutions U.S. Corporation Teaneck, NJ Mar 24, 2015 $65,499
Quality Analyst/Regulatory Analyst Prowess It Solutions LLC Metuchen, NJ Sep 01, 2015 $65,083
Regulatory Affairs Specialist Athenex, Inc. Cranford, NJ Jan 25, 2016 $65,000
Regulatory Affairs Specialist Citron Pharma LLC East Brunswick, NJ Nov 22, 2016 $65,000
Regulatory Affairs Specialist Isolvers Inc. Madison, WI Sep 14, 2016 $65,000
Regulatory Affairs Specialist Belcher Pharmaceuticals, LLC Largo, FL Aug 09, 2016 $65,000 -
$75,000
Regulatory Affairs Specialist I Boston Scientific Corporation Santa Clarita, CA Sep 17, 2016 $65,000

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Top Skills for A Regulatory Affairs Specialist

RegulatoryComplianceFDAProceduresRegulatoryAffairsSafetyReportsDataEntryRegulatoryDocumentsInternalAuditsRegulatoryRequirementsIRBClinicalTrialsRegulatoryAgenciesRegulatorySubmissionsRegulatoryBindersEUAnnualReportsISODossiersRegulatoryStrategiesRegulatoryFilings

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Top Regulatory Affairs Specialist Skills

  1. Regulatory Compliance
  2. FDA
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Reviewed technical and clinical documentation and recommend changes for labeling, manufacturing, and clinical protocol for regulatory compliance.
  • Conduct comment analysis and data mapping against published regulations with an open docket received by the FDA.
  • Evaluated current and changing international medical device regulatory policies/regulations and implemented regulations into company policies and procedures.
  • Advised international clients regarding technical aspects of medical device regulatory affairs.
  • Review and process IND safety reports received from sponsors and cooperative groups.

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