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QMS Regulatory Affairs Specialist (Home, Outdoor, Lifestyle Products)(m/w/x)
Supporting REACH/CLP/Food contact material regulations for Home & Outdoor products in EMEAI. Minimum 2 years regulatory affairs experience in consumer industry required. Flexible work hours, work from home.
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Anforderungen
- University or engineering degree in Science or equivalent
- Minimum 2 years experience in regulatory affairs position, familiar with REACH/CLP/Food contact material regulations within consumer industry in EMEA
- Working knowledge of EN ISO 13485 or ISO 9001 requirements
- Working experience of CE marking and CE compliance process for Food Contact Regulations or WEEE/REACH/RoHs/CLPs, Low Voltage Directive / EMC Directive / Cosmetic regulation
- MS Pack Office proficiency
- Fluency in English
- French language skills
- Authorized to work in Switzerland
Aufgaben
- Support regulatory activities for Home & Outdoor product portfolio
- Support REACH/CLP/Food contact material regulations for EMEAI region
- Back-up regulatory activities for beauty portfolio exceptionally
- Collaborate with product development, compliance, and marketing teams for product compliance
- Prepare and maintain EU Declaration of Compliance
- Prepare and maintain EU Declaration of Conformity
- Review applicable test reports for currency, applicability, and sufficiency
- Review labelling, including marketing materials
- Implement regulatory aspects of labelling
- Maintain regulatory documentation for EMEAI regulatory purposes
- Prepare documentation dossiers for regulatory approvals
- Maintain existing product portfolio regulatory documentation
- Support Middle East and Africa notification and registration
- Support sales demand for assigned product categories
- Participate in QMS maintenance according to ISO 13485
- Update quality documents as needed
- Create quality documents as needed
- Conduct internal audits
- Participate in internal audits
- Develop audit plans
- Lead internal audits
- Prepare audit reports
- Follow up on audit findings
- Participate in notified body audits
- Participate in other inspections
- Collaborate for management review meetings
- Participate in non-conformities process
- Participate in CAPA process for own portfolio
Berufserfahrung
Ausbildung
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Tools & Technologien
Benefits
- Collective Health Insurance
- Gym Allowance
- Mobility allowance
- Flexible work hours
- Work from home
- Increased flexi-days after 1 year
- Swibeco
- Employee discounts on EMEA products
- Modern office
- Collaborative workspaces
- Employee assistance counselling line
- Lunch and Learns
- Company closure between Christmas and New Year’s
- Employee Stock Purchase Plan
- International, diverse, and inclusive environment
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