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Senior Regulatory Affairs Specialist

Santa Clara, CA 95054

Posted: 11/21/2022 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 517596 Is job remote?: No Country: United States

Job Description


Years Experience: 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 opportunity for regulatory affair processes and drive changes to completion. "
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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