Senior RAQA Manager - GSA(m/w/x)

Anforderungen

• Expertise in RAQA and post-market surveillance
• Influential communication and stakeholder representation
• Collaborative cross-functional leadership
• Experience building high-performing teams
• Commitment to continuous process improvement
• BSc degree in relevant field
• Master's Degree or equivalent desired
• RAC preferred
• 10 years' experience and 5+ years supervisory experience
• Project management and time management skills
• Knowledge of MDD, EU MDR, and Quality Systems
• Technical knowledge of medical device requirements
• Ability to manage multiple project workloads
• Ability to lead and develop employees
• Demonstrated leadership skills
• Experience with recruiting and hiring talent
• Demonstrated process improvement skills
• Management of complex multi-region projects
• Ability to lead cross-functional teams
• Organizational influence skills
• Leadership of technical RAQA activities
• Originality and ingenuity in assignments
• Ability to take unreviewed action
• Clear communication with EMEA stakeholders
• Ability to lead regulatory agency meetings
• Preparation of briefings and information documents
• Advisory skills on RAQA requirements
• Engagement with regulators on critical matters
• Ability to create clarity amid complexity
• Openness to diverse ideas and insights
• Ability to relate to diverse people
• Acceptance of scrutiny and feedback
• Preparation of RAQA reporting metrics
• High attention to detail
• Strong IT skills, including Microsoft Office
• Fluency in English and German

Aufgaben

• Lead RAQA operations across the GSA region
• Ensure compliance with EU MDR and Swiss MedDO
• Oversee market access processes and certifications
• Manage regulatory intelligence and documentation
• Define KPIs and performance targets
• Coach and develop regional RAQA teams
• Manage recruiting and onboarding for the local office
• Serve as the Swiss Authorized Representative (CH-Rep)
• Engage with regulators and industry associations
• Drive continuous improvement and system updates
• Lead integration of new acquisitions
• Manage third-party and authority audits
• Report performance and risks to leadership
• Act as a regional subject matter expert
• Collaborate with manufacturing and design divisions
• Develop and implement new regulatory SOPs

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien