Life Unlimited.
At Smith+Nephew, we design and manufacture technology that takes the limits off living. This position oversees Quality and Regulatory activities for the German, Austrian, and Swiss commercial offices and warehouses. The Quality & Regulatory Approval Specialist works closely with the Quality Team at our manufacturing site in Aarau, Smith & Nephew Orthopaedics AG.
This position is located in Zug, Switzerland.
Key Responsibilities:
* Maintain and manage the Quality Management System for DACH warehouses and commercial offices, ensuring compliance and efficiency.
* Develop, review, and improve quality processes and procedures to enhance clarity and regulatory adherence.
* Represent the company in audits and inspections by Certification Bodies, Notified Bodies, and Regulatory Authorities.
* Coordinate product holds, recalls, and complaint-related logistics, ensuring proper quarantine and compliance.
* Administer and support CAPA and Non-Conformance processes, including tracking, reporting, and facilitating corrective actions.
* Manage regulatory reporting and interactions with Competent Authorities for FSCA, vigilance, and post-market surveillance in DACH.
* Oversee regulatory registrations and re-registrations, collaborating with internal and external stakeholders.
* Support supplier management through audits, documentation control, and compliance oversight.
Requirements:
* University degree (Bachelor or Master) in Engineering, Medical Technology, or a STEM subject, or professional training with extensive relevant experience.
* Min. 3 years of experience in Medical Device Quality Assurance or Regulatory Affairs (or in another regulated industry).
* Solid knowledge of Medical Device Regulation (European Union Medical Device Regulation (EU) 2017/745 and other applicable laws and regulations in EU and Switzerland for medical devices).
* Knowledge of ISO 13485:2016, ISO 9001:2015.
* Understanding of Good Distribution Practices.
* Very good German and English language knowledge (written and spoken).
* Travel Requirements: up to 20% within Switzerland, Germany, and Austria.
Benefits:
* Generous Annual Bonus and Pension Schemes.
* Save As You Earn share options.
* 25 Vacation Days per year, plus one extra day off each year for volunteering activities.
* Employee Assistance Program (Mental Health), Life/Accident Insurance, and much more.
* Adaptable working hours and possibility to work from home.
* On-site parking, modern office, free fruit, water, and coffee.