RA Specialist wanting Management (Medical Devices

Regulatory Affairs Specialist – Manager Our client is a well‑known medical device manufacturer with domestic and international presence, seeking a Regulatory Affairs Manager to lead global regulatory efforts. Responsibilities Plan, direct, and execute regulatory activities for EU, US, and ROW markets. Develop and implement strategies to achieve approval or clearance of regulatory submissions. Manage regulatory teams and provide guidance to R&D, Clinical, and QA on submission and compliance requirements. Prepare responses to inquiries from regulatory authorities. Negotiate with regulatory authorities to resolve key issues and secure approvals or clearances in a timely manner. Submit supplements and amendments to update registered product information. Write and obtain acceptance of 510(k) submissions for FDA. Qualifications B.S. degree. Minimum of 10 years of medical device regulatory affairs experience. Ability to travel approximately 10–15 % internationally and domestically. Legally able to work in the United States. All applicant information will be kept confidential according to EEO guidelines. For confidential consideration please email your resume to View email address on click.appcast.io. #J-18808-Ljbffr Carda Life Sciences