Regulatory Affairs Specialist

3 weeks ago

Daly City, United States CareerBuilder Full time

Responsibilities:

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration.

Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.

Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.

Drive product change assessments and define regulatory impact of product changes in global markets.

Review and approve labeling, training, promotional, and advertising material.

Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements.

Ensure compliance with Thermo Fisher Scientific, U.S. FDA, EU MDR/IVDR, Korea MFDS, China NMPA and other international medical requirements.

Participate on audit and field action teams as well as support other post-market activities (e.g. CAPA, HHE, issue assessments).

Facilitate and prepare U.S. regulatory Pre Submission documents and pre submission meetings

Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.

Prepares documents vital for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, PM, De Novo, and technical files for CE marking.

Support global regulatory registration representatives for product global registration activities

Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.

Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team's knowledge of working in a regulated environment.

Assist Regulatory department in the update, improvement, and creation of internal policies and procedures.

Participate in business meetings with external partners as needed.

Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.

Requirements:

A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related

science.

Must have a minimum of 5 years of IVD Regulatory Affairs experience.

This experience must include either 510(k), De Novo, PMA, PMA supplement submissions.

Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.

Excellent knowledge of U.S. and European/International regulations and standards.

RAPS' Regulatory Affairs Certification (RAC).

Experience interacting with FDA and/or other regulatory agencies.

Experience reviewing design specifications and other technical documents.

Previous experience in EU MDD/IVDD or MDR/IVDR.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

#J-18808-Ljbffr

  • International Regulatory Affairs Specialist

    4 weeks ago

    Salt Lake City, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description What will be your activities at bioMrieux?The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist to support Latin America & Canada region in a dynamic regulatory context.The Regulatory Affairs Market team composed of 9 people is in daily contact with the local regulatory teams (subsidiaries and distributors) in order...

  • Regulatory Affairs Intern

    1 week ago

    Jersey City, United States Noven Pharmaceuticals Full time

    Overview: Undergraduate or Graduate student in a Science discipline. This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group. He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects....

  • Regulatory Affairs Intern

    7 days ago

    Jersey City, United States Noven Pharmaceuticals, Inc. Full time

    Undergraduate or Graduate student in a Science discipline.  This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group.  He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects.  Additionally,...

  • Regulatory Affairs Intern

    7 days ago

    Jersey City, United States Noven Pharmaceuticals, Inc. Full time

    Undergraduate or Graduate student in a Science discipline.  This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group.  He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects.  Additionally,...

  • Regulatory Affairs Intern

    2 weeks ago

    Jersey City, New Jersey, United States Noven Pharmaceuticals Full time

    Overview: Undergraduate or Graduate student in a Science discipline.  This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group.  He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects. ...

  • Director Regulatory Affairs-CMC

    1 week ago

    Oklahoma City, United States Disc Medicine Full time

    Disc Medicine is seeking a Director, Regulatory Affairs-CMC to serve as the Regulatory-CMC lead for Disc Medicine’s small molecule program pipeline. This position will have close collaboration with the development teams and visibility to the executive leadership with meaningful opportunities for professional development and career growth.The position...

  • VP, Regulatory Affairs Specialist

    6 days ago

    Jersey City, NJ, United States Jefferies Financial Group Full time

    Regulatory Affairs SpecialistPosition This hire will be a member of the Firm’s Regulatory group which is responsible for exam oversight, branch inspections, regulatory change tracking, governance related tasks and additional ad-hoc tasks.  The Firm’s Regulatory Group is housed within its Legal Department.  While attorneys are encouraged to apply,...

  • Associate Director Regulatory Affairs Ad Promo

    6 days ago

    Oklahoma City, United States EPM Scientific Full time

    Title: Associate Director, Regulatory Affairs Advertising & Promotion The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products...

  • Sr Director, Regulatory Affairs

    3 weeks ago

    Oklahoma City, United States HireMinds Full time

    Our cutting-edge, vaccine client is seeking a Sr. Director, Regulatory Affairs (REMOTE) to their growing team! This role will be accountable for developing regulatory strategies for their vaccine candidates with an emphasis on European requirements for early and late-stage assets. This person will be a key regulatory leader who partners with internal and...

  • Regulatory Compliance Specialist

    6 days ago

    Kansas City, United States Allied Onesource Full time

    Regulatory Compliance SpecialistSenior Regulatory Compliance Specialist: Safeguard Our Success!Do you have a passion for ensuring compliance and mitigating risk in the ever-evolving insurance landscape? Are you a detail-oriented problem solver who thrives in a fast-paced environment? If so, we want YOU!We are seeking a highly motivated and experienced Senior...

  • Regulatory Compliance Specialist

    4 days ago

    Kansas City, United States Allied Onesource Full time

    Regulatory Compliance Specialist Senior Regulatory Compliance Specialist: Safeguard Our Success! Do you have a passion for ensuring compliance and mitigating risk in the ever-evolving insurance landscape? Are you a detail-oriented problem solver who thrives in a fast-paced environment? If so, we want YOU! We are seeking a highly motivated and experienced...

  • Regulatory Compliance Specialist

    2 weeks ago

    Kansas City, Missouri, United States Allied OneSource Full time

    Regulatory Compliance SpecialistSenior Regulatory Compliance Specialist: Safeguard Our SuccessDo you have a passion for ensuring compliance and mitigating risk in the ever-evolving insurance landscape? Are you a detail-oriented problem solver who thrives in a fast-paced environment? If so, we want YOUWe are seeking a highly motivated and experienced Senior...

  • Director, Medical Affairs Operations

    2 weeks ago

    Foster City, United States Mirum Pharmaceuticals Inc Full time

    MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into...

  • Executive Director, Medical Affairs

    1 week ago

    Oklahoma City, United States Morphic Therapeutic Full time

    Description About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...

  • Intern - Regulatory Affairs

    1 week ago

    Foster City, United States Mirum Pharmaceuticals Full time

    If you are not local to the Foster City area, are you willing to relocate? * Yes No I am local Are you currently authorized to work for any employer in the US without visa support? * -- By participating in job interviews, you agree to treat all information shared regarding Mirum’s commercial performance, clinical and scientific data, sensitive corporate...

  • Regulatory Analyst

    4 weeks ago

    Kansas City, United States Talentporte Full time

    Job DescriptionJob DescriptionWe’re seeking a detail-oriented and proactive individual to join our Regulatory team as a Caseworks Regulatory Analyst I. The ideal candidate will possess strong analytical skills, excellent communication abilities, and the capacity to thrive in a fast-paced environment. As a key member of the team, you will be responsible for...

  • Label Compliance Specialist

    21 hours ago

    Salt Lake City, United States Amare Global Full time

    Job DescriptionJob DescriptionAs a Label Compliance Specialist at Amare Global, you will play a crucial role in ensuring that all product labels comply with regulatory requirements set forth by relevant authorities such as the FDA (Food and Drug Administration) and other regulatory bodies. Your attention to detail, and ability to collaborate...

  • Label Compliance Specialist

    3 days ago

    West Valley City, United States Amare Global Full time

    ***Please note that this is HYBRID role where the ideal candidate will be required to work in our Lehi, UT office 1-2 days per week.*** As a Label Compliance Specialist at Amare Global, you will play a crucial role in ensuring that all product labels comply with regulatory requirements set forth by relevant authorities such as the FDA (Food and Drug...

  • Label Compliance Specialist

    6 days ago

    Salt Lake City, Utah, United States Amare Global Full time

    Please note that this is HYBRID role where the ideal candidate will be required to work in our Lehi, UT office 1-2 days per week. As a Label Compliance Specialist at Amare Global, you will play a crucial role in ensuring that all product labels comply with regulatory requirements set forth by relevant authorities such as the FDA (Food and Drug...

  • Label Compliance Specialist

    2 days ago

    Salt Lake City, Utah, United States Amare Global Full time

    As a Label Compliance Specialist at Amare Global, you will play a crucial role in ensuring that all product labels comply with regulatory requirements set forth by relevant authorities such as the FDA (Food and Drug Administration) and other regulatory bodies. Your attention to detail,  and ability to collaborate cross-functionally will contribute to the...