Description
Summary
Our global medical device client is seeking a Director of Regulatory Affairs to serve as a senior leader responsible for defining and executing global regulatory strategies. This role ensures compliant, timely market access and effective lifecycle management across worldwide markets.
The Director will lead end-to-end regulatory problem-solving, drive alignment across regions and functions, and champion the use of AI and digital tools to modernize regulatory operations. This position partners closely with Quality, R&D, Engineering, Clinical, Manufacturing, Supply Chain, and Commercial teams to proactively manage regulatory risk, navigate evolving global requirements, and enable product innovation.
Primary Responsibilities
- Champion company values and foster a strong culture of quality and compliance.
- Develop and execute global regulatory strategies across the U.S., EU, UK, APAC, and emerging markets, informed by market trends and evolving regulatory landscapes.
- Lead resolution of complex, cross-functional regulatory challenges through integrated, end-to-end solutions rather than isolated approaches.
- Provide regulatory leadership across the full product lifecycle, including concept development, design controls, clinical evaluation, submissions, renewals, and post-market activities.
- Assess regulatory impact of product and process changes to inform strategic decision-making and risk management.
- Anticipate and mitigate regulatory risks related to health authority interactions, inspections, design changes, manufacturing transfers, and supplier changes.
- Drive adoption of AI-enabled tools, automation, and advanced analytics to enhance regulatory efficiency, workflow optimization, and intelligence.
- Lead continuous improvement initiatives using data-driven insights to improve submission quality, consistency, and cycle times.
- Establish and maintain global regulatory compliance frameworks, including QMS alignment, certifications (e.g., MDR, MDSAP), and inspection readiness.
- Build, lead, and develop a high-performing Regulatory Affairs team; set clear goals, provide feedback, and support career development.
- Serve as the primary point of contact for regulatory authorities and Authorized Representatives.
- Oversee effective issue resolution processes, including CAPA and nonconformance management.
- Support integration of acquisitions into global regulatory and quality systems.
- Partner with Marketing to review labeling and promotional materials from a regulatory risk perspective
Knowledge/Educational Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- 10+ years of Regulatory Affairs experience in the medical device industry, including global strategy leadership.
- Strong knowledge of global regulatory frameworks, particularly MDR, MDSAP, UKCA, and APAC requirements.
- Proven ability to think strategically and develop scalable, end-to-end regulatory solutions. Demonstrated experience leveraging digital tools, automation, and AI to improve regulatory performance.
- Strong leadership and stakeholder management skills in complex, matrixed global organizations.
- Ability to operate effectively in fast-paced, highly regulated, and ambiguous environments.
- Enterprise mindset with a focus on sustainable, scalable regulatory processes.
- Forward-thinking, with a strong interest in innovation and AI-driven transformation.
- Sound judgment to balance compliance requirements with speed and innovation.
- Excellent written and verbal communication skills across technical and executive audiences.
- Track record of building and developing high-performing teams.
- Proficiency with standard business and enterprise systems (e.g., Microsoft Office, database tools, ServiceMax, Oracle preferred).