Senior Regulatory Affairs Specialist - Plymouth, MN
Only for registered members Plymouth, MN, United States
1 month ago
* This salary range is an estimation made by beBee
Job summary
We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.
Responsibilities
- Preparing documentation for international regulatory registrations and renewals.
- Defining worldwide regulatory requirements necessary for regulatory approval of assigned products.
- Executing product submission strategies as directed.
- Maintaining all regulatory documentation to ensure availability for external audits and preparation of submission packages.
- Maintaining a thorough knowledge of current regulatory requirements.
- Executing on additional responsibilities as defined by management.
Qualifications
- Bachelor's Degree in Science, Engineering, or other relevant discipline and 8+ years' experience in Regulatory Affairs in the medical device industry.
- Working knowledge of quality system regulations and guidelines.
- Great communication skills with all levels of personnel.
- High level of organization and planning skills.
- Working knowledge of medical devices, procedures, and terminology.
Job description
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