EMEA 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

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