Address
Form of workTitle: Senior Regulatory Affairs Specialist
Location: St Paul, MN
Shift: 8:00 a.m - 5:00 p.m.
Job Description:
Location: St Paul, MN
Shift: 8:00 a.m - 5:00 p.m.
Job Description:
- This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
- Assist the strategy implementation and operations for Regulatory Affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Update and develop procedures for the Regulatory Affairs in supporting changes in the regulatory landscape, including EU MDR.
- Identify opportunity for regulatory affair processes and drive changes to completion.
- Have working knowledge in EU MDR.
- Have working knowledge in Regulatory Change Assessment.
- Have working knowledge in US and EU medical device submissions.
- Have experience supporting internal and external inspections.
- Work cross-functionally and in a matrixed environment.
- Have experience with continuous improvement activities.
- BA Degree Required.
- Must have 3-5 years of experiences in Medical Device Regulatory Affairs.
