QMS & Regulatory Affairs Specialist (Medical Devices for Home)

Location: Bussigny, Switzerland; hybrid with 3 days onsite

Company

hirify.global is a global consumer products company managing brands including Braun, PUR, Honeywell, Vicks, Hot Tools, Drybar, Curlsmith, Revlon, OXO, Hydro Flask, and Osprey.

What you will do

• Maintain regulatory documentation and CE compliance for the EMEA product portfolio, with an initial focus on wellness appliances and potential support for medical devices and beauty appliances.
• Compile technical documentation for regulatory approvals, product registrations, and ongoing market compliance.
• Prepare and maintain EU Declarations of Conformity and review product labeling and marketing materials.
• Support notification and registration activities across the Middle East and Africa and provide regulatory guidance to Sales and other business functions.
• Maintain and continuously improve the QMS in accordance with ISO 13485, including quality documentation, management reviews, non-conformities, and CAPA.
• Plan and participate in internal audits, notified body audits, regulatory inspections, and other external assessments.

Requirements

• University or engineering degree in science or an equivalent qualification.
• Ideally 2+ years of experience in regulatory affairs within a product-category area or consumer industry in the EMEA region.
• Working knowledge of EN ISO 13485 and/or ISO 9001 requirements.
• Experience with CE marking and CE compliance for wellness appliances, plus WEEE, REACH, RoHS, and CLP requirements.
• MS Office proficiency.
• Fluent English is mandatory.
• Right to work in Switzerland without requiring sponsorship.

Nice to have

• French language skills.
• Knowledge of the Low Voltage Directive and EMC Directive.

Culture & Benefits

• Permanent, full-time employment at 42 hours per week with flexible working hours and work-from-home options.
• Competitive compensation depending on experience and skills, with collective health insurance or a gym allowance.
• Mobility allowance, increased flexi-days after one year, Swibeco, and employee discounts on EMEA products.
• Modern collaborative office, employee assistance counselling, Lunch and Learns, and an inclusive international environment.
• Company closure between Christmas and New Year’s and an Employee Stock Purchase Plan.