Senior Director, Regulatory Affairs

Job Summary

To drive strategic regulatory and quality integration, the full-time Senior Director, Regulatory Affairs will manage cross-functional partnerships, ensuring quality perspectives inform product development and market strategies while representing the organization externally.

Key Responsibilities:

• Serve as the primary RA/QA leader, shaping regulatory and product strategy in collaboration with Product, R&D, and Operations
• Lead prioritization and governance of RA/QA engagement based on business impact and strategic importance
• Drive simplification and optimization of RA/QA processes to enhance development timelines and align resources with high-value initiatives

Required Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or a related discipline
• 12+ years of experience in Quality Assurance and Regulatory Affairs within biotech, diagnostics, or medical device sectors
• Demonstrated experience in shaping regulatory strategies and supporting product development in regulated environments
• 5+ years of leadership experience, including leading through influence in a matrixed organization
• Proven track record of engaging with external stakeholders, including biopharma partners and regulatory authorities