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Senior Regulatory Affairs Specialist
5 months ago
- Must have 1-3 years of experiences in Medical Device Regulatory Affairs
- Skills: Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessment in 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/BS Degree
Required Duties:
- 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, 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.
