Global Regulatory Affairs Manager, Medical Devices

Carda Life Sciences; Boston (MA); On-site; USD 95,000 - 120,000; Full time

Job summary

Carda Life Sciences is seeking a Regulatory Affairs Manager to lead global regulatory efforts for a well-known medical device manufacturer. The successful candidate will create and implement strategies to achieve regulatory approvals and manage teams across different departments.

Requirements include a B.S. degree and a minimum of 10 years of experience in medical device regulatory affairs. The role involves significant responsibilities including preparing FDA submissions and negotiating with regulatory authorities.

Qualifications

• 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.

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.

Skills

Regulatory Affairs

Team Management

FDA Compliance

Strategy Development

Negotiation

Education

B.S. degree

Job description

Carda Life Sciences is seeking a Regulatory Affairs Manager to lead global regulatory efforts for a well-known medical device manufacturer. The successful candidate will create and implement strategies to achieve regulatory approvals and manage teams across different departments.

Requirements include a B.S. degree and a minimum of 10 years of experience in medical device regulatory affairs. The role involves significant responsibilities including preparing FDA submissions and negotiating with regulatory authorities.