Remote, DEU
48 days ago
Quality & Regulatory Affairs Specialist - Capital Equipment (m/w/d)
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** As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. **How You Create Impact** + Establish, implement and improve service processes, procedures and best practices + Ensure efficiency and accuracy of service department's administrative processes + Coordinate and administrate scheduled maintenance activities, emergency repairs and equipment installations + Participate in special projects and special duties like (re-)validation of technical systems and procedures + Play a key role in growing revenue and margin from spare parts and service contracts + Participate and join strategic initiatives for the service department that align with overall business objectives + Advise general management and work close together with other departments to support the business **What Makes You Stand Out** You have a proven track record in working within Capital Equipment servicing, ideally in Medical Devices or Pharmaceutical industry. You have developped the ability to work both independently as well as in a matrix organisation and to collaborate with stakeholders across all organisation. **What Will Make You Successful** + Knowledge of ISO 13485 and the Medical Device Regulation desirable + Ability to prepare high quality, clear communication materials to the appropriate audience + Advanced IT skills – Excel, PowerPoint, Windchill, SAP + Fluency in German and in English + Discretion and confidentiality EOE/M/F/Vet/Disability
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