Quality and Regulatory Affairs Supervisor (742242)
Job Description
Requisition Number EMEA10534 Employment Type Full-time Location Riyadh<p><br></p>What Is It Like To Work at Zimmer Biomet<p><br></p>At <strong>Zimmer Biomet</strong>, we believe in <strong>The Power of Us</strong>, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.<p><br></p><strong> <u>Zimmer Biomet Offers You An Exciting Position With Good Career Prospects in a Fast-growing International Business, And a Competitive Remuneration Package</u></strong><p><br></p><ul><li>Possibility to grow, develop, and be promoted within a Team</li><li>Friendly, warm and creative atmosphere</li><li>Healthy, inspiring, and international work environment</li><li>Ongoing coaching and talent development</li><li>Access to future career opportunities</li><li>Hybrid work model</li><li>Competitive reward packages</li><li>Annual bonus</li><li>Social and CSR events</li><li>Wellbeing initiatives</li></ul><p><br></p>What You Can Expect<p><br></p>The Quality and Regulatory Affairs Supervisor is responsible of the product registration in different markets in accordance with the local legal requirements. He is also the main contact between the organization and authorities to ensure reliable forward of information.<p><br></p>How You Create Impact<p><br></p> Support implementation, development, maintenance and control of a quality management system according to international standards and corporate guidelines/policies/procedures<p><br></p> Manage customer complaints handling and instructed actions e.g. product blockings, recalls, provide field safety notices, etc. Product enquiries on own responsibility via SAP system are essential required<p><br></p> Responsibility 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<p><br></p> 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<p><br></p> Surveillance and forward of information concerning changes and/or new upcoming local legal requirements to assure the continuity of Zimmer’s business<p><br></p> Support the internal and external audits; also within an internal auditor team coordinated by headquarters (if applicable)<p><br></p> Continuous communication with QA/RA EMEA<p><br></p> Support other Zimmer distribution organizations with regards to QA/RA requirements (e.g. product registrations)<p><br></p> Involvement in special projects and special duties like (re-)validation of technical systems and procedures<p><br></p>What Will Make You Stand Out<p><br></p> Bachelor’s Degree or Master’s Degree in Pharmacy, Business, Engineering<p><br></p> Fluency in English and Arabic, both spoken & written.<p><br></p> French is a plus<p><br></p>What Will Make You Successful<p><br></p> 5 to 10 years of experience in registration activities and/or quality assurance with preference to international medical device regulations.<p><br></p> Microsoft Excel<p><br></p> SAP<p><br></p> Knowledge of ISO 9001, ISO 13485 and Medical Device Directive is a plus<p><br></p> Knowledge of national medical device regulations<p><br></p> Solid problem solving skills<p><br></p> Ability to work independently and under pressure<p><br></p> Organizational, followup and time management skills<p><br></p>Who We Are<p><br></p><strong>Zimmer Biomet</strong> is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to <em>alleviating pain and improving the quality of life for people around the world</em>.<p><br></p><em>Looking to make an impact? Join us and make a difference.</em><p><br></p>Learn more about us by visiting <strong>zimmerbiomet.com</strong>
