Temp Quality & Regultory Affairs Specialist EMEA M / F

Temp Quality & Regulatory Affairs Specialist EMEA M / F

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Temp Quality & Regulatory Affairs Specialist EMEA M / F

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We are ZimVie , a publicly traded, global life sciences company focused on restoring daily life to patients by designing, manufacturing, and distributing innovative tooth replacement and spine surgery solutions. Our company is built on trusted brands, products, and clinical evidence, fostering an inclusive and collaborative culture that empowers our team members to bring their whole selves to work. Together, our diverse global team is shaping an exciting future, and we invite you to be part of it!

About The Role

This role involves maintaining regulatory compliance for products marketed by ZimVie, primarily through communication with Competent Authorities. Responsibilities include preparing and maintaining Technical Documentation, participating in production transfers, and supporting new product development.

What You’ll Be Doing

• Registering products in the EMEA region
• Maintaining and updating health authority databases for medical devices and international registration databases
• Providing requested documents to subsidiaries / distributors according to national laws
• Participating in external audits by Notified Bodies and inspections by Competent Authorities, as well as internal audits of subsidiaries and suppliers
• Responding to market requests from customers, subsidiaries, distributors, and others
• Supporting Customer Service in providing information to customers
• Completing EU MDR pre-incoming inspections
• Preparing documentation for customs clearance
• Assessing new or updated regulations and standards, and communicating updates to regulatory staff
• Preparing, reviewing, approving, distributing, and training on QMS documentation
• Supporting Medical Vigilance activities, including FSCA (Recalls) and FSN for the EU

What You’ll Need

• University degree in health or life sciences
• At least 4 years of practical international medical device regulatory and quality experience; experience with medical devices preferred
• Certified Quality Auditor (CQA) certification is a plus
• Fluency in English and Spanish; additional languages are a plus
• Proficiency in MS Office

What We Offer

Work in a diverse, collaborative global team that values innovation, authenticity, accountability, and growth. Our culture encourages bringing your whole self to work to serve our customers, patients, and colleagues effectively. ZimVie offers a challenging position with good career prospects in an international medical device company, along with benefits such as :

• Competitive compensation
• Partially remote work options
• Employee Assistance Program (EAP)

Want to learn more about us? Click HERE to watch our story.

ZimVie is an Equal Opportunity Employer committed to diversity and inclusion. All qualified applicants will be considered without regard to race, ethnicity, gender, religion, disability, age, or sexual orientation.

• Requisition ID : 3095

Seniority level

• Mid-Senior level

Employment type

• Temporary

Job function

• Quality Assurance
• Medical Equipment Manufacturing

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