Senior Associate supporting compliance solutions for institutional clients in asset management. Delivering regulatory compliance and risk management expertise within a hybrid work environment.
About the role
- Senior Regulatory Affairs Specialist ensuring compliance in medical devices for international markets. Collaborating with cross-functional teams for regulatory submissions and product approvals.
Responsibilities
- Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets.
- Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies.
- Compile and submit documentation as required in support of marketing initiatives.
- Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).
Requirements
- 5+ years of regulatory medical device industry experience.
- RAC Certification preferred.
- Knowledge of regulatory guidelines and requirements (domestic and international).
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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