Regulatory Affairs Specialist

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 recognised.

What You Can Expect

As a Regulatory Affairs Specialist, you are responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products.

This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.

How You'll Create Impact

• Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
• Respond to requests from foreign government and/or distributors as needed.
• Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
• Provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
• Evaluate risk of proposed regulatory strategies; may offer solutions.
• Review proposed labeling for compliance with applicable global regulations.
• Write and manage the development of package inserts.
• Review and evaluate promotion and advertising material for compliance with applicable regulations.
• Review proposed product changes for impact on regulatory status of the product.
• Communicate with regulatory and governmental agencies with supervision.
• Apply FDA regulations to business practices and provides regulatory input, advice and guidance to design teams.

What Makes You Stand Out

You have strong writing, communication, and interpersonal skills, with excellent attention to detail and the ability to manage multiple priorities.

You understand the business environment, the orthopaedic industry, and market dynamics, and you stay current with regulations affecting medical devices, biologics, drugs, and combination products.

In addition, you bring knowledge of FDA, EU, and other applicable regulatory requirements, the ability to identify risk within regulatory strategies, strong problem-solving and negotiation skills,

You build effective cross-functional relationships, communicate confidently at all levels, and are proficient in Microsoft Office Suite and standard computer applications.

Your Background

• Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
• A minimum of one year of experience in orthopaedic or medical device industry preferred
• A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
• Regulatory Affairs Certification (US or EU) preferred
• A combination of education and experience may be considered

Travel Expectations

Up to 15%.

EOE/M/F/Vet/Disability