Regulatoty Affairs Engineer (H/F)

Who We Are?

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.

Looking to make an impact? Join us and make a difference.

Learn more about us by visiting zimmerbiomet.com

What You Can Expect

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.

How You Create Impact

• 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

What Will Make You Stand Out

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.

• 3 to 5 years professional experience in a Quality / Control operational function in the medical device industry or other regulated environment.
• Knowledge of DM ISO 13485, DM 93/42, GMP, FDA
• Knowledge of the 60601-1, 62304 standard
• Practice of audit techniques

What Will Make You Successful

• Rigour and autonomy
• Good written and oral communication
• Diplomacy and contact skills.
• Professional written and spoken English
• General knowledge of the main technologies (software, mechanical) applied to medical devices- In-depth knowledge of quality tools and methods
• Critical thinking, listening skills, good analytical skills and strong qualities of rigour and method.
• Ability to impose the applicable procedures in force, and to demonstrate a certain pedagogical sense
• Ability to work in a team and project management mode

What Is It Like To Work at Zimmer Biomet

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

• Possibility to grow, develop, and be promoted within a Team
• Friendly, warm and creative atmosphere
• Healthy, inspiring, and international work environment
• Ongoing coaching and talent development
• Access to future career opportunities
• Hybrid work model
• Competitive reward packages
• Annual bonus
• Social and CSR events
• Wellbeing initiatives