Zimmer Biomet 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 alleviating pain and improving the quality of life for people around the world.
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Learn more about us by visiting zimmerbiomet.com
Reporting to the Group Regulatory Affairs Director and working closely with other team members and departments, the Regulatory Affairs Engineer will implement the necessary actions to ensure the site's compliance with NF EN ISO 13485, CFR 21 Part 820, 806, Sors 98-282, Directive 93/42/EEC (amended by Directive 2007/47/EC), MDR 2017/745, CFDA and any other standards deemed necessary for the company's development.
• Respect the Group's values
• Ensure product compliance with the standards applicable in the markets where the product is sold
• To manage the processes for the marketing of devices, registrations and their maintenance
• Manage product registration processes in the different countries and ensure their renewal according to commercial needs
• Review proposed product changes to assess their impact on the regulatory status of products and ensure continued compliance with applicable standards
• Organize regulatory monitoring
• Manage the process of reporting changes to the relevant bodies
• Interpret and apply current regulations and standards to company practices and ensure appropriate dissemination of information
• Inform the project development teams about the regulations, their evolution and ensure their application
• Maintain the technical file for CE marking and the design history file in conjunction with the R&D and production departments
• Participate in the marketing/regulatory strategy for the planning of the product launch
• Participate in development projects as an RA representative
• To authorize the release of products if necessary by checking the adequacy between the regulatory status of the products and their destination.
• Ensure regular reporting to the Group Regulatory Affairs Director
The Regulatory Affairs Engineer has an engineering background or equivalent university education. Prior to joining the company, the Regulatory Affairs Engineer may have experience in implementing and leading Quality Management Systems in the medical device industry or in a highly regulated environment.
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
Zimmer Biomet Offers You An Exciting Position With Good Career Prospects in a Fast-growing International Business, And a Competitive Remuneration Package
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence.
With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Our legacy continues to come to life today through our progressive culture of evolution and innovation.