Senior Regulatory Affairs Specialist # JN -062021-66040
Title : Senior Regulatory Affairs Specialist
Location : Little Canada, MN, 55117
Duration : 6+ months contract
- Must have 3-5 years of experiences in Medical Device Regulatory Affairs
- 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
- Have experience with continuous improvement activities
- BA Degree Required
- 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. "