Director, Product Regulatory Affairs

Director, Product Regulatory Affairs

JOB SUMMARY:

The Director, Product Regulatory Affairs, is responsible for developing and implementing global regulatory strategies to support the development, approval, and maintenance of Class III medical devices. This role requires a strategic thinker and effective communicator who can lead cross-functional initiatives, manage regulatory submissions, and interact with global regulatory bodies to ensure compliance and accelerate market access.

Location:

This is an exempt full-time position and located in one of the following locations:

• Baar, Switzerland
• Chesterbrook PA, United States
• Portsmouth NH, United States

Candidates must be either currently located in the area or willing to relocate.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and execute regulatory strategies for new product development and existing product modifications to ensure timely and successful regulatory submissions.
• Prepare, review, and oversee submissions such as PMAs, IDEs, EU MDR Technical Documentation, and international dossiers for Class III medical devices.
• Serve as a regulatory lead in communications and meetings with global regulatory agencies (e.g., FDA, EMA, Notified Bodies, Health Canada).
• Partner with R&D, Clinical Affairs, Quality Assurance, Marketing, and Manufacturing to ensure regulatory input is integrated throughout product development and lifecycle.
• Manage and mentor a team of regulatory professionals, fostering a high-performance culture and ensuring continued staff development.
• Monitor evolving regulatory requirements and proactively assess and mitigate risks related to global product development and market access.
• Ensure regulatory compliance in documentation, labeling, change control, and marketing claims, consistent with global regulations and standards.
• Support audits and inspections by regulatory authorities and ensure continuous inspection readiness.

QUALIFICATIONS/KNOWLEDGE:

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field (Master's or higher preferred).
• 7-10 years of regulatory affairs experience in the medical device industry, with at least 3-5 years in a leadership or management role.
• Strong experience with Class III medical devices, including PMA, IDE, HDE and international registration processes.
• In-depth knowledge of global medical device regulations (21 CFR, Regulation (EU) 745/2017, ISO 13485, MDSAP, ISO 14971).
• Excellent leadership, project management, and communication skills.
• Ability to manage multiple priorities in a dynamic, fast-paced environment.

Knowledge:

• Experience launching Class III devices in multiple global markets.
• Involvement in health authority negotiations, including FDA Advisory Committees or Notified Body reviews.
• Prior experience in business development, portfolio strategy, or lifecycle management.

Why Novocure?

At Novocure, we are revolutionizing cancer care with Tumor Treating Fields (TTFields) therapy, a cutting edge, non-invasive approach that's changing lives. Our mission is clear: together with our patients we strive to extend survival in some of the most aggressive forms of cancer. We're a company with the drive of a startup and the strength of 25 years of success.

Join us in shaping the future of oncology and making a real impact-because every breakthrough begins with courageous thinking.