Medical Devices, Regulatory Affairs Specialist
About The Position
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. About Meta 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.
Requirements
- Bachelor's degree in a scientific discipline or equivalent work experience
- 3+ 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
Nice To Haves
- Master's Degree in Regulatory Affairs
- 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
- RAPS RAC Certification
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Broadcasting and Content Providers
Number of Employees
5,001-10,000 employees
