Title: Regulatory Affairs Specialist
Location: Warsaw, In
Contract: 8/31/26 8/27/27
Number of slots: 6
Job Summary:
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 governments 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
Skills:
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
Education:
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
...Fund Accountant GP Fund Solutions As a Fund Accountant at GPFS, what you do makes an impactdriving client success, supporting investors, and deepening relationships, as you continue to grow and advance your career. Join GP Fund Solutions (GPFS) - a people-first...
...Locations: SAVANNAH GA POOLER GA RINCON GA We are seeking to hire an Oral Surgery/Dental Assistant to join our team. Here we believe in our team, and we make sure you know how valued you are, as a member. We have an atmosphere of positivity and support in...
...Regulatory Affairs Consultant Location: Hybrid (Dallas, TX Preferred) Yrs of Exp: 3 yrs +... ...device regulations, and facilitating market entry strategies. The ideal candidate will... ...assessments to determine the appropriate level of regulatory oversight required....
Biological Science Instructional Support Technician II Job no: 561999 Work type: Staff Location: Fullerton Categories: Unit 9 - CSUEU - Technical Support Services, Administrative, Probationary, Full Time Job Title Biological Science Instructional Support...
Embedded Software Engineer Remote Bright Vision Technologies is a technology consulting and software development company delivering cloud, AI, data, and enterprise solutions across the United States. This is a fantastic opportunity to join an established and well...