Head of Regulatory Affairs (80-100%)

Sotalent; Sankt Gallen; Presencial; CHF 150 000 - 230 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

4.5-day work week

5 weeks annual leave

Resumo da oferta

Sotalent is seeking a Head of Regulatory Affairs – Medical Devices & International Compliance to lead the regulatory function across markets. You will steer strategy, align with EU MDR and FDA requirements, and drive submissions and approvals throughout the product lifecycle.

This role demands strong leadership, cross-functional collaboration, and expertise in technical documentation, submissions, and market access. Fluency in German and English is essential for global interactions.

Qualificações

• Degree in Medical Technology, Biomedical Engineering, Life Sciences or a related discipline.
• Several years of Regulatory Affairs experience within the medical device industry.
• Proven leadership experience and ability to develop and motivate team members.
• Strong knowledge of EU Medical Device Regulation (EU MDR); FDA and other international regulatory experience is advantageous.
• Experience with technical documentation, regulatory submissions and product approval processes.
• Analytical, structured and solution-oriented approach to problem-solving.
• Strong communication, organisation and stakeholder management skills.
• Excellent written and spoken German and English.

Responsabilidades

• Lead, manage and develop the Regulatory Affairs team.
• Oversee regulatory compliance across international markets, with a focus on EU MDR and FDA requirements.
• Prepare, review and maintain technical documentation and regulatory submission packages.
• Coordinate product approvals, registrations and regulatory change applications across global markets.
• Support audits, inspections, regulatory assessments and CAPA.
• Collaborate with Quality Assurance, R&D, Production and other stakeholders.
• Act as primary contact for regulatory authorities, Notified Bodies and external partners.
• Monitor regulatory developments and assess their impact on products, processes and market access.
• Contribute to strategic initiatives that strengthen compliance and support international product launches.

Conhecimentos

Leadership

Regulatory affairs

EU MDR

Regulatory submissions

Stakeholder management

Communication

German & English

Formação académica

Degree in Medical Technology / Biomedical Engineering / Life Sciences

Descrição da oferta de emprego

Head of Regulatory Affairs – Medical Devices & International Compliance

Employment type: Full-time or part-time (80–100%)

Role Overview

Lead the Regulatory Affairs function for an innovative medical device business, overseeing international regulatory compliance, product approvals and market access throughout the product lifecycle. This leadership role combines regulatory strategy, team development and cross-functional collaboration to ensure compliance with EU MDR, FDA and other applicable international regulations.

Key Responsibilities

• Lead, manage and develop the Regulatory Affairs team.
• Oversee regulatory compliance across international markets, with a focus on EU MDR and FDA requirements.
• Prepare, review and maintain technical documentation and regulatory submission packages.
• Coordinate product approvals, registrations and regulatory change applications across global markets.
• Support audits, inspections, regulatory assessments and Corrective and Preventive Actions (CAPA).
• Collaborate with Quality Assurance, Research & Development, Production and other internal stakeholders.
• Act as the primary contact for regulatory authorities, Notified Bodies and external partners.
• Monitor regulatory developments and assess their impact on products, processes and market access.
• Contribute to strategic initiatives that strengthen compliance and support international product launches.

Requirements

• Degree in Medical Technology, Biomedical Engineering, Life Sciences or a related discipline.
• Several years of Regulatory Affairs experience within the medical device industry.
• Proven leadership experience and the ability to develop and motivate team members.
• Strong knowledge of EU Medical Device Regulation (EU MDR); FDA and other international regulatory experience is advantageous.
• Experience with technical documentation, regulatory submissions and product approval processes.
• Analytical, structured and solution-oriented approach to problem-solving.
• Strong communication, organisation and stakeholder management skills.
• Excellent written and spoken German and English.
• Leadership role with significant scope for strategic input and decision-making.
• International working environment focused on innovative medical technologies.
• Short decision-making processes and opportunities to implement new ideas.
• 4.5-day working week and five weeks of annual leave.
• Collaborative team culture and long-term career prospects.