Quality & Regulatory Approval Specialist (f/m/x) with German

vor 2 Wochen

Zug, Schweiz Smith & Nephew Vollzeit

Quality & Regulatory Approval Specialist (f/m/x) with German

This position is responsible for overseeing the Quality and Regulatory activities of the German, Austrian, and Swiss (DACH) commercial offices and warehouses, across the several franchises of Smith+Nephew. The Quality & Regulatory Approval Specialist is also working closely with the Quality Team of our manufacturing site in Aarau, the Smith & Nephew Orthopaedics AG.

This position is located in Zug, Switzerland.

What will you be doing?

  • 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.

What will you need to be successful?

  • University degree (Bachelor or Master) in e.g. Engineering, Medical Technology or a STEM subject or professional training with extensive relevant experience.
  • Min. 3 years 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.

Beneficial:

  • Accredited Quality certificate (e.g. SAQ Quality Manager), or equivalent.
  • Experience working in a global company with international teams.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion, Diversity and Equity: We are committed to Welcoming, Celebrating and Thriving on Diversity.

Benefits: Generous Annual Bonus and Pension Schemes, Save As You Earn share options.

Work/Life Balance: 25 Vacation Days per year as well as one extra day off each year for volunteering activities.

Your Wellbeing: Employee Assistance Program (Mental Health), Life/Accident Insurance and much more.

Flexibility: Adaptable working hours and possibility to work from home.

Extra Perks: On-site parking, a modern office and free fruit, water & coffee.

Please apply with your CV (PDF, English) and feel free to not include personal information like e.g. age, photo, nationality or family status.

Smith+Nephew is an equal opportunity employer. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Smith & Nephew GmbH, Merve Krabbenhöft (she/her), Talent Acquisition Specialist, Theilerstrasse 1A, 6300 Zug.

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