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Regulatory Affairs Senior Specialist M / F
Job Function : Regulatory
We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission.
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 :
* Prepare CERs for the Technical Documentations
* Prepare post-market surveillance reports
* Prepare biocompatibility reports
* Maintain and prepare Technical Documentations according to EU MDR requirements
* Review new regulatory requirements and implement them accordingly
* Support QMS maintenance including alignment with QMS of ZimVie
* Support R&D in the development of new products
* Prepare and submit 510(k)
* Participate in External and Internal audits
What you'll need :
* University degree in a Science related subject (e.g., 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)
* Strong communication and organizational skills
* Fluent in English; other European languages are a plus
* Initiative, flexibility, and ability to work as a team player
* Willingness 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.
ZimVie offers you a challenging position with good career prospects in an international medical device business and the following benefits :
* Competitive compensation package
* Permanent contract
* Partially remote work option available
* Private life, health, and dental insurance
ZimVie 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.
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