About this opportunity
Carda Life Sciences lists this RA Specialist wanting Management (Medical Devices opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.