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Position: QMS and Regulatory Affairs Specialist Medical Devices
Work Location: Switzerland
Type: Full time, Permanent hybrid
Join Us as a Regulatory Affairs Specialist – EMEA
Are you passionate about ensuring products meet the highest standards of safety and compliance? Reporting directly to the QMS & Regulatory Affairs for EMEA, you’ll play a key role in supporting regulatory activities across our diverse product portfolio. Your primary focus will be on medical devices and wellness appliances, with opportunities to expand into the exciting world of beauty technology.
In this role, you’ll help navigate complex regulatory landscapes, ensuring our innovative products are compliant and ready to make a positive impact across the EMEA region. If you're detail-oriented, proactive, and eager to grow in a fast-pa
Key Responsibilities
Regulatory Affairs – Medical Devices & Wellness Products:
1. Ensuring regulatory documentation is current and compliant across the EMEA region, including CE mark maintenance.
2. Compiling and submitting regulatory dossiers to secure timely approvals and support portfolio continuity.
3. Owning all aspects of Technical Documentation for assigned projects under MDR 2017/745.
4. Preparing and managing change assessment files for Notified Body submissions.
5. Leading MDR transition activities for designated legacy devices.
6. Collaborating cross-functionally with Product Development, Marketing, and other teams to uphold product compliance.
7. Drafting and maintaining EU Declarations of Conformity and Compliance.
8. Review product labelling and marketing materials to ensure regulatory accuracy.
9. Monitor and support Clinical Evaluation documentation and processes.
10. Assisting with product registration and notification across Middle East, Africa, and APO regions.
11. Providing regulatory support aligned with sales demand for assigned product categories.
Quality Management System – ISO 13485:
12. Contributing to the ongoing maintenance and improvement of the QMS, including updating and creating quality documentation.
13. Leading and participating in internal audits—from planning and execution to reporting and follow-up (Certified Internal Auditor).
14. Actively supporting external audits, including those conducted by Notified Bodies and other regulatory inspections.
15. Collaborating in Management Review Meetings, providing insights and updates on quality performance.
16. Managing assigned non-conformities, ensuring timely resolution and documentation.
17. Participating in the CAPA (Corrective and Preventive Action) process to drive continuous improvement.
18. Overseeing software validation activities for EMEA, ensuring compliance with ISO 13485 (where applicable).
Skills and Qualifications needed to be successful in this role:
19. Fluency in English is required, fluency in French would be an asset.
20. You must be authorized to work in Switzerland on a full-time basis
21. University or engineering degree in Science or equivalent
22. Ideally Minimum 2 years’ experience in a regulatory affairs position in the required product category(ies) (medical & active device experience preferred) and/or consumer industry in EMEA region
23. Working knowledge of EN ISO 13485 and/or ISO 9001 requirements
24. Working experience of the CE marking and CE compliance process plus WEEE/REACH/RoHs/CLPs for Medical Device. Knowledge of Low Voltage Directive / EMC Directive would be an asset
25. MS & Office suite proficiency
26. Excitement about joining a midsize yet growing company with fast-growing brands!
What do we offer?
27. Competitive compensation package depending on experience and skills
28. Collective Health Insurance or Gym Allowance
29. Mobility allowance
30. Flexible work policy with regards to working hours and work from home
31. Increased flexi-days package after 1 year of service
32. Swibeco (CH)
33. Modern office with collaborative workspaces
34. Employee assistance counselling line
35. Employee discounts on all our EMEA products
36. Lunch and Learns
37. Company closure between Christmas and New Year’s
38. Employee Stock Purchase Plan
39. The chance to work in an international, diverse, and inclusive environment!