• Medical Devices, Regulatory Specialist

    Meta (New York, NY)


    Summary:

    We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative devices.

    Required Skills:

    Medical Devices, Regulatory Specialist Responsibilities:

    1. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager

    2. Support regulatory compliance activities, including site registration, audits, post-market vigilance reporting, product recalls, etc., as needed

    3. Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed

    4. Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions

    Minimum Qualifications:

    Minimum Qualifications:

    5. Bachelor’s degree in a scientific discipline or equivalent work experience

    6. 3+ years of industry experience in medical device regulatory affairs or related industry

    7. Experience working with minimal supervision and under general direction only

    8. Experience multitasking, supporting multiple projects, functioning on a global basis, prioritizing, conducting team meetings, and meeting project deadlines

    Preferred Qualifications:

    Preferred Qualifications:

    9. Experience with Food and Drug Administration requirements, guidance documents, Active Medical Device Directive/EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards

    10. Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) or in Regulatory Affairs

    11. Regulatory Affairs Professionals Society Regulatory Affairs Certification

    12. Demonstrated experience in negotiation skills, authoring technical reports and submissions, and presenting to cross functional peers and leadership

    Public Compensation:

    $90,000/year to $137,000/year + bonus + equity + benefits

    **Industry:** Internet

    Equal Opportunity:

    Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.

     

    Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at [email protected].