1d ago
Regulatory Affairs Senior Specialist - Supply Chain
Switzerland
โจ $90k-$130k / yearest.
full-timesenior Remotehealthcare
๐ผ About This Role
You'll ensure regulatory compliance across EMEA supply chains, managing documentation, vigilance reporting, and label standards. You'll act as a regional SME ensuring audit readiness and product safety across markets. This role offers exposure to international regulatory operations in a fast-moving environment.
๐ฏ What You'll Do
- Ensure site-level regulatory compliance and audit readiness across EMEA.
- Manage medical device vigilance activities and regulatory submissions.
- Prepare and maintain documentation for import/export and trade compliance.
- Oversee product and site compliance including EPR and label standards.
๐ Requirements
- Proven experience in regulatory affairs within medical devices or life sciences.
- Strong knowledge of EU MDR, vigilance reporting, and SDS standards.
- Excellent written/verbal communication in a multicultural environment.
- High attention to detail in documentation and record management.
โจ Nice to Have
- Experience with regulatory authorities or notified bodies.
- Audit/inspection exposure and EPR scheme knowledge.
- Professional certifications in regulatory affairs or quality management.
๐ Benefits & Perks
- ๐ International exposure across EMEA regions.
- ๐ผ Professional training and ongoing development.
- ๐ Flexible working arrangements (remote/hybrid).
- ๐ง Wellbeing resources and standard benefits.
- ๐ค Inclusive environment with equal opportunity.
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter Screenยท 30 min
- 2Hiring Manager Interviewยท 45 min
- 3Technical/Case Interviewยท 60 min
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