Regulatory Affairs Specialist

Stryker Switzerland seeks a Regulatory Affairs Specialist in Biberist to manage product registrations and compliance for Switzerland and the DACH region, ensuring adherence to MDR and Swiss legislation.

The company is looking for a professional to handle regulatory and quality assurance tasks for the German, Swiss, and Austrian markets. The primary goal is to maintain compliance with MDR 2017/745 and Swiss laws while driving product registrations and improving quality management systems.

Responsibilities

• Manage product registration and lifecycle maintenance for Switzerland and the broader GSA region, including the preparation and upkeep of regulatory documents.
• Coordinate Swiss regulatory submissions and notifications, such as Swissmedic applications, ensuring data accuracy and full compliance.
• Monitor regulatory updates for MDR and Swiss MedDO, performing impact assessments and implementing necessary changes.
• Provide daily regulatory and quality support to internal teams like Supply Chain, Customer Service, and Technical Service.
• Assist with Quality Management System processes, including SOP updates, records management, and training support.
• Prepare for and support internal and external audits related to regulatory and quality topics.
• Participate in cross-functional projects to enhance regulatory and quality assurance processes.

Requirements

• Bachelor's degree in Engineering, Science, or a related discipline.
• At least two years of experience in Regulatory Affairs and Quality Assurance within the medical device, pharmaceutical, or a similarly regulated industry.
• Fluency in both English and German.

Nice to have

• Master’s degree.
• Hands-on experience with regulatory submissions, product registration maintenance, QMS support, change control, or compliance activities.
• Understanding of MDR 2017/745, Swiss medical device legislation (MedDO), and Swiss market requirements like CH-REP.
• Familiarity with Swiss regulatory tools such as Swissdamed or similar registration databases.
• Experience supporting QMS documentation, including SOP changes, training deployment, and audit support.
• Strong stakeholder management skills and a focus on continuous improvement.