Job Description
Role: Senior Regulatory Affairs Specialist
Location: Lake Forest, IL - 60045
Duration: 08 Months
Description:
Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs
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, 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. "
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
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