Associate Director Regulatory Affairs

Becton Dickinson Medical Devices • San Diego, CA

1d • Onsite

About The Position

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. The role includes but is not limited to the development and implementation of regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including variations and renewals, interacting with global internal stakeholders as well as external consultants/service providers in support of registration activities, developing and maintaining documentation for compliance programs such as labeling, promotional material review, and other regulatory requirements.

Requirements

• Bachelor’s degree science STEM engineering
• Minimum of 10 years of relevant experience in the medical device industry within Quality and/or R&D, including at least 5 years in Regulatory Affairs.
• Must have hands-on experience with complex medical device systems and software, specifically Class II or higher devices.
• Experience working with external service providers, consultants, and regulators.
• Minimum of 1–2 years of proven experience in people management, including team leadership and performance oversight.
• Demonstrated interpersonal skills necessary to optimally collaborate across departments and geographies required

Nice To Haves

• Advanced degree, master’s degree or higher preferred with a focus in a scientific discipline preferred
• Familiarity with Infusion Pump Systems preferred
• Regulatory Affairs Certification (RAC) preferred
• Project Management Certification preferred

Responsibilities

• Lead regulatory submission activities for various initiatives
• Work closely with cross-functional teams on submission strategy and documentation development for new product submissions
• Coordinate interactions between internal stakeholders and external service providers to ensure timely completion of submission milestones
• Assist in the maintenance of departmental systems used to track projects and ongoing operational activities
• Directly interface with regulators as needed

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees