Senior Clinical Affairs Manager

Job Overview

We are seeking an experienced Senior Manager of Clinical Affairs to lead the planning, execution, and management of our regulatory and quality support. This role is critical for generating the reports with clinical evidence required to achieve regulatory approvals (FDA, CE Mark, etc.), support market access, and ensure post-market surveillance compliance. The ideal candidate is a leader with a deep understanding of medical device regulations, with good project management skills to lead the team and monitor timeline.

Strategic Planning & Leadership

• Lead, mentor, and develop a team of clinical affairs professionals (e.g. CRAs, Clinical Information manager).
• Plan and execute the regulatory support reports in alignment with product development and regulatory submission timelines.
• Provide clinical expertise and guidance to cross-functional teams including R&D, Regulatory Affairs, Marketing, and Quality Assurance.

Regulatory Compliance & Quality

Qualifications & Experience

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