Head of Regulatory Affairs (80-100%) in St. Gallen

pHead of Regulatory Affairs – Medical Devices International Compliance /ppbEmployment type: /b Full-time or part-time (80–100%) /ph3Role Overview /h3pLead 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. /ph3Key Responsibilities /h3ulliLead, manage and develop the Regulatory Affairs team. /liliOversee regulatory compliance across international markets, with a focus on EU MDR and FDA requirements. /liliPrepare, review and maintain technical documentation and regulatory submission packages. /liliCoordinate product approvals, registrations and regulatory change applications across global markets. /liliSupport audits, inspections, regulatory assessments and Corrective and Preventive Actions (CAPA). /liliCollaborate with Quality Assurance, Research Development, Production and other internal stakeholders. /liliAct as the primary contact for regulatory authorities, Notified Bodies and external partners. /liliMonitor regulatory developments and assess their impact on products, processes and market access. /liliContribute to strategic initiatives that strengthen compliance and support international product launches. /li /ulh3Requirements /h3ulliDegree in Medical Technology, Biomedical Engineering, Life Sciences or a related discipline. /liliSeveral years of Regulatory Affairs experience within the medical device industry. /liliProven leadership experience and the ability to develop and motivate team members. /liliStrong knowledge of EU Medical Device Regulation (EU MDR); FDA and other international regulatory experience is advantageous. /liliExperience with technical documentation, regulatory submissions and product approval processes. /liliAnalytical, structured and solution-oriented approach to problem-solving. /liliStrong communication, organisation and stakeholder management skills. /liliExcellent written and spoken German and English. /liliLeadership role with significant scope for strategic input and decision-making. /liliInternational working environment focused on innovative medical technologies. /liliShort decision-making processes and opportunities to implement new ideas. /lili4.5-day working week and five weeks of annual leave. /liliCollaborative team culture and long-term career prospects. /li /ul #J-18808-Ljbffr