Quality & Regulatory Affairs Manager (m/f/d)

Job title: Quality & Regulatory Affairs Manager (m/f/d)

Industry: Medical Devices

Skills: Quality, Regulatory, CE Marking, ISO 13485

Start date: ASAP

Location: Zurich, Switzerland

The Aristo Group is a Recruitment focused solution provider in the life sciences industry. Our goal is to find the “perfect match” for our customers and candidates.

We are now looking for an experienced QA/RA Manager to join a Global MedTech company to work on innovative products benefiting the healthcare of millions.

Main duties

• Overseeing and implementing regulatory compliance for all medical devices in portfolio (ISO 13485)
• Handling the submission, maintenance, and renewal of product approvals in various sales markets
• Engaging and maintaining communication with relevant regulatory authorities
• Identifying, generating, and renewing product approvals within sales markets
• Assisting in the planning and execution of both internal and external audits
• Collaborating in the management review process
• Conducting post-market surveillance and managing risks effectively

Qualifications

• Bachelors degree in a scientific field
• Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM)
• Demonstrated enjoyment and proficiency in managing and maintaining quality documents with precision
• Adaptable team player with a structured approach, capable of thriving in dynamic work environments
• Ability to perform well under pressure and adeptly prioritize tasks
• Fluent in English, French or German advantageous

For further information about this position, please apply with your CV or contact me directly via linkedIn.

*Please note, only those with the right to work in Switzerland can apply*