Novocure · 3 hours ago
Senior Director, Clinical Regulatory Affairs
Portsmouth, NH
Full-time
Onsite
Director/Executive
10+ years expNovocure is seeking an experienced and strategic Sr. Director of Clinical Regulatory Affairs to lead and execute global clinical regulatory strategies for their Class III medical device programs. This leadership role is critical in supporting clinical trial design, regulatory submissions, and interactions with global health authorities to enable successful development and approval of high-risk medical devices.
BiotechnologyHealth CareMedical DeviceOncology
Responsibilities
Develop and lead clinical regulatory strategies for Class III medical devices from early development through market approval
Interpret and apply complex regulatory requirements to clinical trial planning and execution
Collaborate with cross-functional teams including Clinical Affairs, Quality, R&D, and Regulatory Operations
Author, review, and submit high-quality clinical regulatory documentation, including IDEs, PMAs, EU CTAs, and Design Dossiers
Ensure submissions meet the latest regulatory requirements and are completed on schedule
Serve as primary regulatory contact for clinical matters with global health authorities (FDA, Notified Bodies, EMA, etc.)
Lead and prepare teams for pre-submission meetings, advisory panels, and inspections
Provide regulatory guidance on clinical trial protocols, informed consent forms, and investigator brochures
Ensure compliance with applicable clinical trial regulations (e.g., 21 CFR 812, ICH-GCP, MDR, ISO 14155)
Lead, mentor, and develop a high-performing team
Actively participate in internal governance, risk assessments, and go/no-go decisions related to clinical development
Qualification
Required
Bachelor's degree in life sciences, biomedical engineering, or a related field required; advanced degree preferred
Minimum of 10 years of regulatory affairs experience in the medical device industry, with at least 5 years in a leadership capacity
Deep knowledge and hands-on experience with Class III medical devices, including IDEs, PMAs, and CE Mark submissions
Proven experience interacting with FDA and other global regulatory bodies on clinical issues
Strong understanding of clinical trial design, statistical principles, and regulatory requirements for high-risk medical devices
Excellent leadership, communication, and cross-functional collaboration skills
Preferred
Experience with novel technologies or breakthrough device designation
Familiarity with digital health, software as a medical device (SaMD), or combination products
Prior experience in global regulatory strategy, especially EU MDR and Asian markets
Company
Novocure
An Oncology Company Pioneering a Novel Therapy for Solid Tumors
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1BKey Investors
Pharmakon AdvisorsJP Morgan ChaseBioPharma Credit
2024-05-02Post Ipo Debt· $100M
2020-11-09Post Ipo Debt· $150M
2020-11-05Post Ipo Debt· $575M
Leadership Team
Asaf Danziger
Chief Executive Officer
Mike Ambrogi
Chief Operating Officer
Recent News
2025-12-22
2025-12-03
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