Senior Director, Regional Regulatory Affairs

Novocure Inc.; Baar; Vor Ort; CHF 130’000 - 190’000; Vollzeit

Zusammenfassung

A leading company in oncology is seeking a Senior Director of Regional Regulatory Affairs in Baar, Switzerland. The role involves developing regulatory strategies for Class III medical devices, ensuring compliance, and leading a successful team. Ideal candidates will have significant experience in regulatory affairs and a strong understanding of medical device regulations.

Qualifikationen

• 15+ years of regulatory affairs experience in the medical device industry.
• At least 8 years in a leadership capacity.
• Proven track record of Class III medical device submissions.

Aufgaben

• Develop and lead regional regulatory strategies aligned with global business goals.
• Ensure regulatory compliance of labeling and promotional materials.
• Lead and develop a high-performing regional regulatory team.

Kenntnisse

Leadership

Communication

Regulatory Compliance

Project Management

Ausbildung

Bachelor’s degree in a scientific discipline

Advanced degree (MS, PhD, PharmD, or equivalent)

Jobbeschreibung

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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.

To manage a team in Baar, Switzerland we are looking for a

Senior Director, Regional Regulatory Affairs

Location: This role isbased at our Global Headquarters in Baar, Switzerland. Candidates must be either currently located in the Zug area or willing to relocate.

The Senior Director of Regional Regulatory Affairs is a strategic leadership role responsible for the development, implementation, and execution of regional regulatory strategies for Class III medical devices. The individual will ensure regulatory compliance and drive regulatory approvals to support the company’s commercial objectives in the region. This role requires extensive collaboration with global and cross-functional teams to influence business outcomes and align with the overall regulatory strategy.

Your responsibilities:

Regulatory Strategy & Leadership

• Develop and lead regional regulatory strategies aligned with global business goals and product development timelines.
• Review registration and submit to regional regulatory authorities (e.g., FDA, EMA, Health Canada, PMDA) and participate in key agency interactions and negotiations.

Compliance & Risk Management

• Monitor and interpret evolving regional regulatory requirements and communicate changes to internal stakeholders.
• Ensure regulatory compliance of labeling, advertising, promotional materials, and product changes to meet regional requirements.
• Manage inspection readiness and support inspections and audits by regulatory agencies.

Team Management & Development

• Lead and develop a high-performing regional regulatory team.
• Mentor and coach staff to support career development and performance excellence.

Cross-functional Collaboration

• Collaborate with R&D, Clinical Affairs, Quality Assurance, Legal, Marketing, and Commercial teams to ensure regulatory alignment and support business priorities.
• Provide regulatory input into business development and due diligence activities.

Your profile:

• Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• 15+ years of regulatory affairs experience in the medical device industry, with at least 8 years in a leadership capacity.
• Proven track record of successful Class III medical device submissions and approvals in the designated region.
• Strong understanding of international and regional medical device regulations (e.g., FDA, MDR, ISO 13485, MDSAP).
• Experience with combination products or neuromodulation technologies is a plus.
• Exceptional leadership, communication, and influencing skills.
• Strategic thinker with a strong business acumen and the ability to manage complex regulatory challenges.
• Strong project management skills and the ability to prioritize in a fast-paced environment.