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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 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.
Seniority level
* Director
Employment type
* Full-time
Job function
* Product Management and Marketing
Industries
* Pharmaceutical Manufacturing
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