What are the responsibilities and job description for the Regulatory Affairs Specialist position at Zimmer Biomet?
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 be join our CMF&T team (craniomaxillofacial & thoracic solutions).
This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submissions process.
How You'll Create Impact
Up to 15%.
EOE/M/F/Vet/Disability
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 be join our CMF&T team (craniomaxillofacial & thoracic solutions).
This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submissions process.
How You'll Create Impact
- Assists 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.
- Responds to requests from foreign government and/or distributors as needed.
- Assists with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
- Evaluates risk of proposed regulatory strategies; may offer solutions.
- Reviews proposed labeling for compliance with applicable global regulations.
- Writes and manages the development of package inserts .
- Reviews and evaluations promotion and advertising material for compliance with applicable regulations.
- Reviews proposed product changes for impact on regulatory status of the product.
- Communicates with regulatory and governmental agencies with supervision.
- Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams.
- Strong writing, communication, and interpersonal skills
- Strong attention to detail; ability to multi-task and balance competing priorities
- Knowledge of overall business environment, the orthopaedic industry, and the marketplace
- Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
- Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
- Knowledge of FDA, EU, and other regulatory body regulations
- Ability to identify risk in Regulatory strategies
- Strong problem solving skills
- Effective negotiating skills
- Basic computer skills, including Microsoft Office Suite
- 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
Up to 15%.
EOE/M/F/Vet/Disability