Must have 3-5 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 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, 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 opportunities for regulatory affair processes and drive changes to completion.
