Job Description:
This position is responsible for overseeing the Quality and Regulatory activities of the German, Austrian, and Swiss (DACH) commercial offices and warehouses across several franchises of Smith+Nephew.
The Quality & Regulatory Approval Specialist works closely with the Quality Team of our manufacturing site in Aarau, the Smith & Nephew Orthopaedics AG.
Responsibilities:
* Maintain and manage the Quality Management System for DACH warehouses and commercial offices to ensure 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 to ensure 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 a relevant field such as Engineering, Medical Technology, or a STEM subject, or professional training with extensive relevant experience.
* Minimum 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.
* Excellent German and English language skills (written and spoken).
* Travel Requirements: up to 20% within Switzerland, Germany, and Austria.
Desirable Qualifications:
* Accredited Quality certificate (e.g. SAQ Quality Manager), or equivalent.
* Experience working in a global company with international teams.
About Us:
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:
We offer a range of benefits, including Generous Annual Bonus and Pension Schemes, Save As You Earn share options, 25 Vacation Days per year, and more.