Smith & Nephew
Job title:
Quality & Regulatory Approval Specialist (f/m/x) with German
Company
Smith & Nephew
Job description
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.This position is responsible for overseeing the Quality and Regulatory activities of the German, Austrian, and Swiss (DACH) commercial offices and warehouses, across to 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 efficiencyDevelop, review, and improve quality processes and procedures to enhance clarity and regulatory adherenceRepresent the company in audits and inspections by Certification Bodies, Notified Bodies, and Regulatory AuthoritiesCoordinate product holds, recalls, and complaint-related logistics, ensuring proper quarantine and complianceAdminister and support CAPA and Non-Conformance processes, including tracking, reporting, and facilitating corrective actionsManage regulatory reporting and interactions with Competent Authorities for FSCA, vigilance, and post-market surveillance in DACHOversee regulatory registrations and re-registrations, collaborating with internal and external stakeholdersSupport supplier management through audits, documentation control, and compliance oversightWhat 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 experienceMin. 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 devicesKnowledge of ISO 13485:2016, ISO 9001:2015Understanding of Good Distribution PracticesVery good German and English language knowledge (written and spoken)Travel Requirements: up to 20% within Switzerland, Germany and AustriaBeneficial:Accredited Quality certificate (e.g. SAQ Quality Manager), or equivalentExperience working in a global company with international teamsYou. 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. Learn more about our on our website.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, so we can give back to our communities!Your Wellbeing: Employee Assistance Program (Mental Health), Life/Accident Insurance and much moreFlexibility: Adaptible working hours and possibility to work from homeExtra Perks: On-site parking, a modern office and free fruit, water & coffeePlease 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#LI-MK1#LI-HYBRIDStay connected and receive alerts for jobs like this by joining our .We’re more than just a company – we’re a community! Follow us on to see how we support and empower our employees and patients every day.Check our for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.
Expected salary
Location
Zoug
Job date
Sun, 02 Mar 2025 00:55:58 GMT
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