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

Position Summary:

We are seeking an experienced and strategic Sr. Director of Clinical Regulatory Affairs to lead and execute global clinical regulatory strategies for our Class III medical device programs. This leadership role will be critical in supporting clinical trial design, regulatory submissions, and interactions with global health authorities (e.g., FDA, EMA, PMDA) to enable successful development and approval of cutting-edge, high-risk medical devices.

Key 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.

Qualifications:

• 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

• 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.

Leadership Competencies

• Executive Presence: Articulates complex regulatory and business issues clearly and confidently to senior leaders, regulatory authorities, and external stakeholders.
• Strategic Thinking: Connects regional nuances with global strategy; sees the full product lifecycle and regulatory interdependencies from early development to commercialization.
• Influencing and Stakeholder Management: Excels in managing cross-functional and cross-regional relationships in a matrixed organization; drives alignment without direct authority.
• Decisive Leadership: Makes timely, data-driven decisions in uncertain or complex regulatory environments; balances regulatory risk with business opportunity.