Temp Quality

Temp Quality & Regulatory Affairs Specialist EMEA M/F

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Temp Quality & Regulatory Affairs Specialist EMEA M/F

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Join to apply for the Temp Quality & Regulatory Affairs Specialist EMEA M/F role at ZimVie

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 product registration, participation in internal and external audits, and in new product development.

What You'll Be Doing

• Registrations of products in EMEA area
• 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 accordance with national laws.
• Participate in external audits by Notified Bodies (NBs) and inspections by Competent Authorities (CAs), and perform internal audits for subsidiaries and suppliers.
• Respond to all market requests (customers, subsidiaries, distributors, and others).
• Support Customer Service in providing information to customers.
• Complete EU MDR Pre-incoming inspections.
• Prepare documentation required for customs clearance.
• Assess new or updated regulations and standards applicable to the products, and national laws for any revisions. Communicate updates to regulatory staff.
• Prepare, review, approve, distribute, and train on QMS documentation.
• Support Medicovigilance activities (e.g., FSCA Recalls and FSN for EU area).

What You'll Need

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

What We Offer

Working within a diverse and collaborative global team that embraces 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 package
• Temporary contract
• Meal allowance
• Partially remote work option
• Learning & development programs
• Employee Assistance Program (EAP)

Interested in learning 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: 3094

Seniority level

• Mid-Senior level

Employment type

• Temporary

Job function

• Quality Assurance

Industries

• Medical Equipment Manufacturing

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