Address
Form of work Responsibilities:
Requirements:
- Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices.
- Reviews and summarizes post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications.
- Evaluates and documents all alleged reportable events and field action reviews/assessments. Prepares and submits all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes. Follows-up, as required, for failure investigations associated with reportable events. Interacts with the FDA and other regulatory authorities on all MDR or reportable events.
Requirements:
- Bachelor of Science degree in a relevant discipline required.
- Minimum 5 years of experience in medical device Regulatory Affairs with RAC certification or 3 years of experience w/o certification.
- Strong pre-market regulatory experience particularly in the international pre-market arena (example: EU MDR Tech File submissions)
- Demonstrated knowledge of FDA QSR, ISO 13485, MDD, MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements.
- Knowledge of Japanese, Australian, and Brazilian requirements preferred.
- Demonstrated knowledge of ISO 14971 and ISO 10993.
- Experience with preparing and filing reportable events (MDRs) and Vigilance Reports.
- Previous experience with FDA regulatory submissions and CE marking.
- Experience interacting with regulatory bodies, such as the FDA and Notified Body.
- Experience with the Biocompatibility testing process preferred.
