Regulatory Affairs Specialist for Medical Devices
hace 1 día
We are ZimVie, a leading global life sciences company dedicated to restoring daily life for our patients through innovative medical solutions. Our mission is built on a legacy of trusted brands and products, supported by an inclusive culture that empowers our team members to bring their best selves to work every day.
About the RoleThe Regulatory Affairs Senior Specialist EMEA will lead and prepare technical documentation, including biocompatibility, clinical, and post-market surveillance reports. This role will assist the Global Regulatory Affairs Manager with topics related to clinical affairs, regulatory compliance, and regulatory affairs.
Key Responsibilities- Prepare CERs for Technical Documentations
- Maintain and prepare Technical Documentations according to EU MDR requirements
- Review new regulatory requirements and implement them accordingly
- Support QMS maintenance and alignment with ZimVie's QMS
- Participate in External and Internal audits
To be successful in this role, you will need:
- University degree in a Science-related subject (e.g., Biology, Biotechnology, Pharmacy)
- 5 years' experience in a similar position
- SME in ISO 10993, ISO 14155, ISO 13485, EU MDR implementation, FDA 21 CFR 820, and submission of 510(k)
- Fluent in English; other European languages are a plus
ZimVie offers a challenging position with good career prospects in an international medical device business, along with:
- Competitive compensation package: $80,000 - $110,000 per annum, depending on experience
- Permanent contract
- Meal allowance
- Partially remote work option available
- Private life, health, and dental insurance
- Learning & development program
This is an exciting opportunity to join our diverse and collaborative global team, embracing innovative curiosity, personal authenticity, accountability, and a growth mindset.
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