Job Title: Senior Regulatory Affairs Specialist
Location: St. Paul, MN, 55117
Duration: 6 Months
- Exempt/Non-Exempt: Non-Exempt
- Years' Experience: 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.
- Work cross-functionally and in a matrixed environment.
- Have experience with continuous improvement activities.
Education: 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.