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Medical Devices, Regulatory Affairs Specialist
2 days ago
You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative consumer focused devices.
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
