Beschreibung

You will drive regulatory excellence across the GSA region by leading high-performing teams and ensuring strict compliance. Your day-to-day involves strategic leadership, from managing audits to shaping the regional RAQA mission.

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

Tools & Technologien

Benefits