Regulatory Affairs & QMS Specialist, Medical Devices (EMEA)

Helen of Troy; Bussigny; Hybrid; CHF 100,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Gym allowance

Mobility allowance

Flexible work policy

Flexi-days after 1 year

Swibeco

Modern office

Employee assistance counselling line

Employee discounts

Lunch and Learns

Company closure between Christmas and

Employee Stock Purchase Plan

Inclusive environment

Job summary

Helen of Troy is hiring a QMS & Regulatory Affairs Specialist (Medical Devices for Home) in Bussigny, Switzerland. The role focuses on wellness appliances with potential support for Medical Devices across the EMEA region, reporting to the Associate Quality & Regulatory Affairs Director EMEA.

The position is hybrid (3 days onsite) and permanent, full time (42 hours per week). You will drive regulatory documentation, EU Declarations of Conformity, and cross-functional collaboration to ensure

Qualifications

• University or Engineering degree in Science or equivalent.
• 2+ years’ experience in regulatory affairs in EMEA.
• Working knowledge of EN ISO 13485 and ISO 9001.
• Experience with CE marking and CE compliance for wellness appliances; WEEE/REACH/RoHs/CLPs; LVD/EMC asset.
• MS Office proficiency.
• English fluent; French a plus.

Responsibilities

• Maintain regulatory documentation for the EMEA product portfolio and CE marking requirements.
• Prepare technical docs to support registrations and market compliance.
• Collaborate with Product Development, Marketing, Quality and cross-functional teams.
• Prepare EU Declarations of Conformity and review labeling for regulatory compliance.
• Support notification/registration activities across Middle East and Africa.
• Provide regulatory guidance to Sales and other functions.

Skills

Regulatory affairs

Quality systems

CE marking

ISO 13485 knowledge

EMC Directive

English fluency

Right to work in Switzerland

Education

University/Engineering degree

Tools

MS Office

Job description

Helen of Troy is hiring a QMS & Regulatory Affairs Specialist (Medical Devices for Home) in Bussigny, Switzerland. The role focuses on wellness appliances with potential support for Medical Devices across the EMEA region, reporting to the Associate Quality & Regulatory Affairs Director EMEA.

The position is hybrid (3 days onsite) and permanent, full time (42 hours per week). You will drive regulatory documentation, EU Declarations of Conformity, and cross-functional collaboration to ensure