The Senior Manager of Regulatory Affairs will lead regulatory activities for the Dispensing Platform, including new product submissions and existing product registrations worldwide
Job Summary
The Senior Manager of Regulatory Affairs will lead regulatory activities for the Dispensing Platform, including new product submissions and existing product registrations worldwide.
This role emphasizes collaboration with global internal teams and external consultants to ensure timely regulatory approvals and compliance.
BD offers a culture that supports learning, growth, and innovation with a strong commitment to diversity, inclusion, and employee well-being.
Matching Summary
The Senior Manager of Regulatory Affairs will lead regulatory activities for the Dispensing Platform, including new product submissions and existing product registrations worldwide.
Salary
Base: $158,300.00 - $261,100.00 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Regulatory strategy development
Product registration management
Cross-functional team collaboration
Project management skills
Regulatory compliance documentation
Interaction with regulators
Microsoft Office proficiency
Nice-to-have
Mentoring and team leadership
Proactive problem solving
Strong interpersonal skills
Attention to detail
Travel flexibility up to 10%
Experience with software controlled devices
Knowledge of Software as Medical Device (SaMD)
Key Requirements
Bachelor's degree in Science, Engineering, or Business
Minimum 10 years relevant experience in Medical Device industry
At least 5 years managing regulatory teams
Experience with external service providers and regulators