Quality & Regulatory Affairs Associate

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

The Quality and Regulatory Affairs Associate is responsible of the product registration in different markets in accordance with the local legal requirements. You will also be the main contact between the organization and authorities to ensure reliable forward of information.

How You'll Create Impact

Top Level

• Support the implementation, maintenance, continuance, and control of a quality management system according to international standards and corporate guidelines/policies, where applicable
• Assure an effective, consistent, and reliable forward of information in terms of product surveillance in assigned region and local market in accordance with legal requirements and Zimmer Biomet procedures and as per instructions of the direct manager, where applicable
• Ensure the surveillance and forward of information concerning changes and/or new upcoming local legal requirements to assure the continuity of Zimmer Biomet’s business in assigned region
  
  

Detailed Tasks

• Support implementation, development, maintenance, and control of a quality management system according to international standards and corporate guidelines/policies/procedures
• Be responsible for product registration on the market in accordance with local legal requirements; main contact for the local competent authority and responsibility for the maintenance of the business in the local market
• Assure an effective, consistent and reliable forward of information in terms of product surveillance on the local market in accordance with legal requirements and Zimmer procedures Surveillance and forward of information concerning changes and/or new upcoming local legal requirements to assure the continuity of Zimmer Biomet’s business
• Support the internal and external audits; also within an internal auditor team coordinated by headquarters (if applicable)
• Be in continuous communication with QA/RA EMEA
• Support other Zimmer Biomet distribution organizations with regards to QA/RA requirements (e.g., product registrations)
• Get involved in special projects and special duties like (re-)validation of technical systems and procedures
  
  

What Makes You Stand Out

• Experience with Windows Office Software, SAP eligible
• English language is a basic requirement
• Solid problem solving skills
• Ability to work independently and under pressure
• Organizational, follow up and time management skills
  
  

Your Background

• B.S. degree in engineering, business, political science or equivalent experience
• 0 to 3 years’ experience in registration activities and/or quality assurance
  
  

EOE/M/F/Vet/Disability

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