Spain Job Openings
ZimVie US Corp LLC
Regulatory Affairs Senior Specialist EMEA M/F
FULL TIME
November 29, 2024
About the role:
Lead and prepare technical documentation, including biocompatibility, clinical, and post-market surveillance reports. Assist the Global Regulatory Affairs Manager with topics related to clinical affairs, regulatory compliance, and regulatory affairs.
What you’ll be doing:
- To prepare CERs for the Technical Documentations
- To prepare post-market surveillance reports
- To prepare biocompatibility reports
- Maintain and prepare Technical Documentations according to EU MDR requirements
- To review new regulatory requirements and implement them accordingly
- Support QMS maintenance including alignment with QMS of Zim Vie
- Support R&D in the development of new products
- To prepare and submit 510(k)
- To participate in External and Internal audits
What you’ll need:
- University degree in a Science related subject (eg Biology, Biotechnology, Pharmacy, etc)
- 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)
- Communications and organizational skills
- Fluent in English. Other European languages is a plus
- Initiative, flexibility and team player
- Possibility to travel to Spain, Italy and Germany
What we offer:
Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset. Our culture empowers us to bring our whole selves to work each day, so we can be at our best when serving our customers, patients, and colleagues.
Zim Vie offers you a challenging position with good career prospects in an international medical device business and following benefits:
- Competitive compensation package
- Permanent contract
- Meal allowance
- Partially remote work option available
- Private life, health and dental insurance
- Learning & development program
Do you want to know more about us? Click HERE to watch our story.
Zim Vie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity.
Zim Vie generally does not sponsor applicant work visas for this position.
- Requisition ID: 2906
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