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Senior Regulatory Affairs Specialist

Saint Paul, MN 55102

Posted: 03/21/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 547276 Is job remote?: No Country: United States

Job Description

Target PR Range: 40-45
*Depending on experience

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.

?• Help with our international regulatory team to decipher product skus that can be released to different geography (product release authorization process)
• Need to have some understanding of global medical device regulations
• Good at data crunching, cross-referencing different database to provide evidence of proof of particular geography product release
• Provide EU MDR documentation to international affiliates for their in-country submissions
• Be a liaison between our EP International Reg Ops group, and Shared Service Reg Ops and our BU RA submission team to sort through discrepancies on product skus and make sure we confirm correct ones should be released to particular geography
• Manage and assist countries submission documents that leverage CE mark approval

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 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
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