Quality & Regulatory Affairs Specialist EMEA M/F

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:

This role will be responsible for performing duties to maintain regulatory compliance for products marketed by ZimVie, with a primary emphasis on communications with Competent Authorities. Responsibilities include the preparation and maintenance of Technical Documentation and participation in production transfers and new product development.

What you’ll be doing:

• Participate in regulatory global Submissions.
• Maintain and update Health Authorities databases for Medical Device placing in the market and commercialization, as well as international internal databases on registrations.
• Provide requested documents to each subsidiary/distributor in the on a case-by-case basis and in accordance with National laws.
• Responsible to ensure the adequacy of all labelling and IFUs to International Standards.
• Participate in the assessments of the new or updated regulations and standards applicable to the products, and national laws for any new or updated revisions. Communicate updates to regulatory staff.
• Participate in the preparation of the technical documentation.
• Preparation of change notifications to the notified body when required.
• Participate in the production transfer and Operational Projects plans as needed.
• Support to the R&D team in the design and development plans according to the global strategy, representing the RA department.
• Support to the Quality audits.
• Support to the maintenance and improvements of the QMS related with the subsidiaries and distributors based on ISO 13485:2016 for Dental products.
• Participate if requested in internal and external audits and any responses to cited issues being the ownership of corrective actions stemming from these audits.
• Answer market requests related with QARA topics.
• Perform Regulatory/Quality trainings to employees as well as subsidiary contacts.

What you’ll need:

• University degree in health of life science related subject.
• 4 years in practical international medical device regulatory and quality experience. Experience with medical devices or similar is preferred.
• Certified Quality Auditor (CQA) preferred.
• Fluent in English & Spanish. Other languages is a plus.
• MS Office.

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
• Meal alowance
• 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.

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.

• Requisition ID: 2907