Job Description
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Regulatory Affairs Specialist
Summary of the Role/About the Team & Org
ADI’s Digital Healthcare Group is developing novel remote monitoring solutions that improve patient care and quality of life, while keeping costs low. The Digital Healthcare Group is looking for an energetic, Principal Regulatory Affairs Specialist for the development of novel solutions.
Specific Responsibilities / Duties
Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering FDA regulations
Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
Participate in negotiations and interactions with regulatory authorities during the development and review process
Support international product registrations ...
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