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Medical Devices, Regulatory Affairs Specialist
2 weeks ago
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 consumer focused devices.
Medical Devices, Regulatory Affairs Specialist Responsibilities:- 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
- Support regulatory compliance activities, including site registration, audits, post-market vigilance reporting, product recalls, etc., as needed
- 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
- Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions
- Bachelor's degree in a scientific discipline or equivalent work experience
- 6+ years of industry experience in medical device regulatory affairs or related industry
- Experience working with minimal supervision and under general direction only
- Experience multitasking, supporting multiple projects, functioning on a global basis, prioritizing, conducting team meetings, and meeting project deadlines
- Master's Degree in Regulatory Affairs
- RAPS RAC Certification
- Extensive knowledge of applicable regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)
- Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
- Experience with development and regulations for medical devices intended for direct to consumer health wearables
- Demonstrated lead in preparing a 510k or Technical Dossier
Meta builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Apps like Messenger, Instagram and WhatsApp further empowered billions around the world. Now, Meta is moving beyond 2D screens toward immersive experiences like augmented and virtual reality to help build the next evolution in social technology. People who choose to build their careers by building with us at Meta help shape a future that will take us beyond what digital connection makes possible today—beyond the constraints of screens, the limits of distance, and even the rules of physics.
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 accommodations-
$116,000/year to $168,000/year + bonus + equity + benefits
Individual compensation is determined by skills, qualifications, experience, and location. Compensation details listed in this posting reflect the base hourly rate, monthly rate, or annual salary only, and do not include bonus, equity or sales incentives, if applicable. In addition to base compensation, Meta offers benefits. Learn more about benefits at Meta.
