Location:

Portsmouth, NH, US, 03801 Wayne, PA, US, 19087 CH

Description:

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.

Nearest Major Market: Portsmouth
Nearest Secondary Market: Boston

Novocure GmbH

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Director, Product Regulatory Affairs