AtriCure Verified 35h ago
Regulatory Affairs Specialist
Mason, OHAll locationsMason, OHMinneapolis, MN Hybrid
Salary not listedPaySalary not listed
TypeNot specified
Work settingHybrid
Verified listing
JobFig found this opening at its original source and checks that it remains available.
About the role
This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will also maintain internal documentation of such approvals and handle requests for documentation from our international distributors and customers. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
What you'll bring
- Bachelor’s degree in a technical/scientific/life science discipline required or 3+ years of Regulatory experience in the medical device industry
- Proficient on programs within Microsoft Office
- Written and verbal communication skills
- Problem solving and/or troubleshooting experience
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Occasional travel may be required
- Minimum of 2 years of experience in the medical device industry
- Basic knowledge of U.S. and/or European/International regulations and standards
- Strong understanding of documentation within a quality management system
- Team oriented and able to effectively manage and prioritize multiple projects
- General knowledge of medical terminology
Benefits
401(k)Parental Leave
Locations
Mason, OHMinneapolis, MN