Regulatory Affairs Sr Specialist
- Hiring from
- United States
- Work type
- Remote
- Posted
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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
- Assist with the assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process; author and publish electronic submissions.
- Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates.
- Assist with 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 and develop regulatory strategy for new products.
- Evaluate risk of proposed regulatory strategies and offers solutions.
- Review proposed labeling for compliance with applicable US and international regulations.
- Write, manage, and approve the development of package inserts.
- Review, evaluate, and approve promotion and advertising material for compliance with applicable regulations.
- Review proposed product changes for impact on regulatory status of the product.
- Interpret and apply FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.
- Communicate with regulatory and governmental agencies.
How You'll Create Impact
What Makes You Stand Out
Requires a Bachelor’s degree in engineering management, engineering, life sciences, or related field, or foreign equivalent.
Must have 5 years of experience in job offered or related position.
Requires 1 year of experience with Orthopedic or medical device industry.
Requires 3 years of experience with the following:
- Knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.
- Working with medical product and anatomic knowledge.
- Interpreting and applying FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams
Your Background
Requires a Master’s degree in engineering management, engineering, life sciences, or related field, or foreign equivalent.
Must have 3 years of experience in job offered or related position.
Requires 1 year of experience with Orthopedic or medical device industry.
Requires 3 years of experience with the following:
- Knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.
- Working with medical product and anatomic knowledge.
- Interpreting and applying FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.
Role permits full-time remote work throughout the U.S.
Physical Requirements
Travel Expectations
- Role requires up to 15% domestic travel.
EOE/M/F/Vet/Disability
