Job Description

Join our team at Helen of Troy and make an immediate impact on our trusted brands: , , , , , , , , , , and , and Together, we build innovative and useful products that elevate people's lives everywhere every day.
Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and bathroom. We are already making your everyday lives better. We are powered by knowledgeable, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. Whether you are just starting your career or in need of a challenge, we recognize, develop, and empower talent!
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:

• Ensuring regulatory documentation is current and compliant across the EMEA region, including CE mark maintenance.
• Compiling and submitting regulatory dossiers to secure timely approvals and support portfolio continuity.
• Owning all aspects of Technical Documentation for assigned projects under MDR 2017/745.
• Preparing and managing change assessment files for Notified Body submissions.
• Leading MDR transition activities for designated legacy devices.
• Collaborating cross-functionally with Product Development, Marketing, and other teams to uphold product compliance.
• Drafting and maintaining EU Declarations of Conformity and Compliance.
• Review product labelling and marketing materials to ensure regulatory accuracy.
• Monitor and support Clinical Evaluation documentation and processes.
• Assisting with product registration and notification across Middle East, Africa, and APO regions.
• Providing regulatory support aligned with sales demand for assigned product categories.

Quality Management System - ISO 13485:

• Contributing to the ongoing maintenance and improvement of the QMS, including updating and creating quality documentation.
• Leading and participating in internal audits--from planning and execution to reporting and follow-up (Certified Internal Auditor).
• Actively supporting external audits, including those conducted by Notified Bodies and other regulatory inspections.
• Collaborating in Management Review Meetings, providing insights and updates on quality performance.
• Managing assigned non-conformities, ensuring timely resolution and documentation.
• Participating in the CAPA (Corrective and Preventive Action) process to drive continuous improvement.
• Overseeing software validation activities for EMEA, ensuring compliance with ISO 13485 (where applicable).

?Skills and Qualifications needed to be successful in this role:

• Fluency in English is required, fluency in French would be an asset.
• You must be authorized to work in Switzerland on a full-time basis
• University or engineering degree in Science or equivalent
• 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
• Working knowledge of EN ISO 13485 and/or ISO 9001 requirements
• 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
• MS & Office suite proficiency
• Excitement about joining a midsize yet growing company with fast-growing brands!

What do we offer?

• ? Competitive compensation package depending on experience and skills
• ? Collective Health Insurance or Gym Allowance
• ? Mobility allowance
• ? Flexible work policy with regards to working hours and work from home
• ? Increased flexi-days package after 1 year of service
• ? Swibeco (CH)
• ? Modern office with collaborative workspaces
• ? Employee assistance counselling line
• ? Employee discounts on all our EMEA products
• ? Lunch and Learns
• ? Company closure between Christmas and New Year's
• ? Employee Stock Purchase Plan
• ? The chance to work in an international, diverse, and inclusive environment!

Wondering if you should apply? Helen of Troy welcomes people as diverse as our brands! Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you.
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Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, and Revlon - many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity.
At Helen of Troy, our strategy involves acquiring brands that we can integrate and enhance, amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally, we are committed to providing innovative solutions tailored to consumers, operational excellence, global scalability, and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry, propelling our brands to unparalleled heights of success and recognition worldwide.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.

Skills Required