Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
DF
Hybrid Senior Regulatory Affairs Specialist, Omnipod 5 Expansion
Posted last month
About the role
- Senior Regulatory Affairs Specialist leading regulatory submissions for medical devices at Insulet Corporation. Ensuring compliance and collaboration across product development and marketing teams in the medical field.
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.
- Partner with Marketing and Development teams to provide support to currently-marketed products as necessary.
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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