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 recognized.
What You Can Expect
Provide support to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance.
Role based at Global Business Service Centre (GBS) Poland - reporting directly to QARA Manager based in the UK.
How You'll Create Impact
Product registrations
• Provide EMEA regions with support on product registration process
• Maintain product registration database
• Collect and review relevant documentation to support product registration
• International Registration Request (IRR) Process- support implementation of Windchill IRRs. Once process is implemented- process, review and monitor IRRs
• Change Notifications- Windchill- process and review Change Notifications for relevant regions
• Tender- Support regions with tender requests by providing information and documentation as required
Product Complaints
• Support Product Complaints process by working closely with GBS Complaint processing team; assisting with follow up questions, supporting product returns, preparing monthly reports.
Documentation Control
• EMEA harmonization project- Ensure that processes are kept up to date through review, approval, distribution and subsequent handling of obsolete documents according to the guidelines established in EMEA.
Training
• Ensure all new/ updated procedures are trained out via ILearn in relevant countries to ensure compliance of our employees.
What Makes You Stand Out
• Being able to work both independently as well as in matrix organisation
• Ability to collaborate with stakeholders across all organisation
• Ability to prepare high quality, clear communication materials to the appropriate audience.
• Discretion and confidentiality
Your Background
• Experience in working with / within Quality functions in Medical Devices/ Pharmaceutical Industry
• Advanced IT skills – Excel, PowerPoint, Windchill, SAP
• Knowledge of ISO 13485 and Medical Device Regulations desirable
• English- High standard of English / writing, presentation skills. Other languages beneficial.
Travel Expectations
0-5%
EOE/M/F/Vet/Disability