Manager, Regulatory Affairs- Biomaterials
$117k - $201.25kJohnson & Johnson Diabetes Care Companies
Manager, Regulatory Affairs position supporting biomaterials, biologics, and combination products within Johnson & Johnson's Orthopaedics division. Responsible for developing regulatory strategies, managing submissions, and providing leadership across cross-functional teams to advance product development and global commercialization.
Responsibilities
- Lead regulatory activities for biomaterials, biologics, and combination products across development, submission, and lifecycle stages
- Develop and execute risk-based regulatory strategies for pipeline development and global launch readiness
- Prepare and maintain regulatory submissions including BLAs, IDEs, PMAs, and other required documentation
- Partner with cross-functional teams and external partners to evaluate opportunities and implement regulatory strategies
- Provide leadership, technical guidance, and training to regulatory colleagues and project teams
Requirements
- Expertise in Chemistry, Manufacturing, and Controls (CMC) and Current Good Manufacturing Practice (CGMP)
- Experience with regulatory submissions including BLAs, IDEs, PMAs, 510(k)s, and De Novo requests
- Knowledge of biologics, combination products, and medical device regulations
- Demonstrated ability to develop risk-based regulatory strategies and manage complex submissions
- Leadership experience with proven cross-functional collaboration and team management skills
- Understanding of global regulatory requirements and agency interaction
Vacancy posted 11 days ago
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