Regulatory Affairs Specialist Medical Devices

306 Health & Home Europe SARL (CH); Bussigny; Hybrid; CHF 90,000 - 120,000; Full time

Benefits offered by this job

Collective Health Insurance

Mobility allowance

Flexible work policy

Lunch and Learns

Employee discounts on products

Job summary

306 Health & Home Europe SARL (CH) is seeking a dedicated QMS & Regulatory Affairs Specialist to support the EMEA portfolio of wellness and home devices. You will report to the Associate Quality & Regulatory Affairs Director EMEA and help ensure compliance across CE, ISO 13485, and related regulations.

Based in Bussigny, Switzerland, this permanent, full-time role (42 hours/week) offers hybrid work with flexible hours and opportunities to influence regulatory strategy across multiple brands

Qualifications

• University or Engineering degree in Science or equivalent.
• 2+ years' regulatory affairs experience in EMEA or consumer products.
• Solid knowledge of EN ISO 13485 and ISO 9001 requirements.
• Experience with CE marking and CE compliance for wellness appliances.
• Familiarity with WEEE/REACH/RoHS/CLP regulations.
• Knowledge of Low Voltage Directive/EMC directives is an asset.
• Fluent in English; French is advantageous.

Responsibilities

• Maintain regulatory documentation for the EMEA product portfolio.
• Prepare and support EU Declarations of Conformity and product registrations.
• Collaborate with Product Development, Marketing, and Quality to ensure compliance.
• Support notifications and registrations in Middle East and Africa regions.
• Provide regulatory guidance to Sales and other functions.
• Assist in QMS maintenance and internal audits as part of ISO 13485.

Skills

Regulatory affairs

ISO 13485 knowledge

CE marking

WEEE/REACH/ROHS

EMC/Low Voltage Directive

English fluent

Right to work in CH

MS Office proficiency

Education

University or Engineering degree in Science or equivalent

Tools

MS Office

Job description

QMS & Regulatory Affairs Specialist (Medical Devices for Home)

Our Beauty & Wellness division empowers consumers with trusted products that support self-care, from salon-quality styling tools to wellness devices like humidifiers and air purifiers. Our innovative products and solutions promote healthy living, elevating the lives of consumers every day. This business unit includes Braun, PUR, Honeywell, Vicks, Hot Tools, Drybar, Curlsmith, and Revlon brands, and this role may support one or more of these brands. 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!

What you will be doing:

Reporting to the Associate Quality & Regulatory Affairs Director EMEA, the regulatory affairs specialist supports all regulatory activities for the entire product portfolio focusing first on Wellness appliances but could be also support on Medical Device, Beauty appliances, all distributed in the EMEA region.

Position: QMS & Regulatory Affairs Specialist (Medical Devices for Home)

Department: Regulatory

Work Location: Bussigny, Switzerland - Hybrid (work 3 days onsite)

Work Type: Permanent, Full time (42 hours per week)

Regulatory Affairs (80% focus on Wellness Appliances)

• Maintaining regulatory documentation to ensure compliance of the EMEA product portfolio, including CE marking requirements.
• Compiling and maintaining technical documentation to support timely regulatory approvals, product registrations, and ongoing market compliance.
• Collaborating closely with Product Development, Marketing, Quality, and other cross-functional teams to ensure and maintain regulatory compliance.
• Preparing and maintaining EU Declarations of Conformity.
• Reviewing product labeling and marketing materials to ensure regulatory compliance, while supporting additional product categories as required.
• Supporting notification and registration activities across the Middle East and Africa regions.
• Providing regulatory guidance and support to Sales and other business functions for assigned product categories.

Quality Management System (QMS)

• Participating in the maintenance and continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485 requirements, including creating and updating quality documentation as needed.
• Conducting and participating in internal audits, including audit planning, audit execution, report preparation, and follow-up of audit findings.
• Actively participating in notified body audits, regulatory inspections, and other external assessments.
• Contributing to Management Review meetings by providing quality and compliance-related input.
• Managing assigned non-conformities and supporting timely resolution activities.
• Participating in Corrective and Preventive Action (CAPA) processes, including investigation, implementation, and effectiveness monitoring.

Skills and Qualifications needed to be successful in this role:

• University or Engineering degree in Science or equivalent
• Ideally 2+ years' experience in a regulatory affairs position in a product categories area 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 for wellness appliances plus WEEE/REACH/RoHs/CLPs.
• Knowledge of Low Voltage Directive / EMC Directive would be an important asset
• MS Pack Office proficiency
• Fluency in English mandatory, French would be an asset
• Right to Work in Switzerland without requiring sponsorship

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
• 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!

Want to join us?

We are proudly powered by our exceptional people, who feel and act like passionate owners. Every day, their experience and skills build superb businesses and create best-in-class capabilities in every corner of our company. We cultivate careers and celebrate our shared success as we create long-term sustainable value together. With over 50 years of experience, we are just getting started. We elevate lives. We soar together. We are Helen of Troy.

Our Values

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.

Founded in 1968, Helen of Troy is a leading global consumer products company with operations across North America, South America, Europe, and Asia. Our portfolio includes trusted brands such as OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, Revlon, and Olive & June – many of which rank among the top brands in their consumer goods categories.

The above statements are intended to describe the general nature and level of work performed and are not intended to be an exhaustive list of responsibilities. Management reserves the right to modify the duties and responsibilities of the position at any time.