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Regulatory Affairs Senior Specialist EMEA M/F Job Function: Regulatory
Location: Cornella de Llobregat, B, ES
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. Together, our dedicated, diverse global team is shaping an exciting future, and we hope you'll consider being a part of it!
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)
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.
ZimVie offers you a challenging position with good career prospects in an international medical device business and following benefits:
Competitive compensation package
Permanent contract
Partially remote work option available
Private life, health and dental insurance
Do you want to know more about us? Click HERE to watch our story.
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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