FGB'ers gave this company a 4/5 in overall job satisfaction
FGB’ers working at Zimmer Biomet rated their manager’s support a 4.5/5
Workplace flexibility with on-site, remote, or partial remote work assignments.
Global ERGs, including Women-Inspired Network, sponsored by executive leadership & focused on professional networking, growth, development
Family-friendly benefits and support for new parents including multiple paid leave options, adoption assistance and wellness programs
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.
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.
· 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 · Provides 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 · 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%
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.
Compensation range: $72,000 - $95,000
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.