Regulatory Affairs Specialist II
A rapidly growing medical device organization is seeking a driven and detail‑oriented Regulatory Affairs Specialist II to join their Minneapolis team. This is an opportunity to step into a hands‑on role supporting innovative, life‑saving technologies while working closely with cross‑functional partners across product development, quality, and risk management. The ideal candidate brings strong communication skills, a solutions‑oriented mindset, and a passion for navigating complex regulatory pathways.
The Regulatory Affairs Specialist II should have the following qualifications:
- Bachelor's degree or Master's degree in Engineering or technical field
- 5+ years of prior regulatory affairs experience in the medical device field
- High proficiency in preparing and filing successful 510k submissions
- Willingness to work fully on-site at our Columbus, OH location
- Ability to successfully work with cross functional and risk management teams
Regulatory Affairs Specialist II will be responsible for…
- In this role, you will provide regulatory support to medical device projects from initial kickoff all the way to post-marketing
- Coordinate and prepare global regulatory submission documents with appropriate input from cross-functional teams
- Develop and maintain procedures and work instructions to maintain compliance with applicable regulations
- Collaborate with product development teams to support execution of global regulatory strategies
- Keep abreast of relevant regulations and inform team about potential impact of changes
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