Regulatory Affairs - Global Medical Devices Companies - several opportunities / Switzerland

Regulatory Affairs - several opportunities - global Medical Devices companiesResponsibilities:

• Lead the development of new systems and procedures, support regulatory processes for products market access
• Participate in technical audit and related activities (internal audits and inspections)
• Coordination and preparation of document packages for regulatory submissions for new products
• Be compliant with local and regional registration requirements and company policies
• Compiles all materials required in submissions, license renewal and annual registrations.
• Recommend changes for manufacturing, labelling, marketing and clinical protocol for regulatory compliance
• Tracking/control systems, keeping abreast of regulatory procedures and changes

Requirements:

• BSc; MSc degree in Life Sciences
• Experience of working within the Medical Device field
• Regulatory experience with EU regulatory requirements and processes for post approval activities
• Experience in managing product portfolios within a Regulatory Affairs position on the Global Market
• Fluent English, B2/C1 German or French (depending on clients’ location)

What to expect:

• Detailed conversation and introduction to all roles and clients with an experienced consultant
• Transparency and support throughout the application process
• Negotiation with clients for better work/contract conditions
• Follow up and update on market relevant opportunities

Notes: The responsibilities may differ depending on our clients’ needs

Experience in within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.