Job Description

Job Description Summary

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our MedTech products—to find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, 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.

This role provides flexibility to work 4 days at our San Diego site and Friday remotely.

Summary of Job Responsibilities

The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. The role includes developing and implementing regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations, and developing and maintaining documentation for compliance programs.

Key Accountabilities

• Lead 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.
• Perform additional tasks as required.

Education

• Bachelor’s degree in a scientific discipline or equivalent.
• Advanced degree preferred.
• Regulatory Affairs Certification (RAC) and Project Management Certification preferred.

Experience

• Minimum 10 years of relevant work experience in the Medical Device industry.
• Minimum of 5 years in Regulatory Affairs with complex medical device systems and software strongly preferred.
• Experience working with external service providers, consultants, and regulators required.
• Familiarity with Infusion Pump Systems preferred.
• Ability to travel up to 20% domestically and internationally may be required.

Skills & Competencies

• Strong project management skills and organizational abilities.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Demonstrated interpersonal skills necessary to collaborate across departments and geographies.
• Proactive approach to problem solving with strong attention to detail.
• Team player who takes initiative.

At BD, we prioritize on-site collaboration to foster creativity and innovation essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence. Remote or field-based positions will have different workplace arrangements.

For certain roles at BD, employment is contingent upon proof of being fully vaccinated against COVID-19. In some locations, COVID-19 testing may be available and/or required.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. It’s a place where we help each other be great, do what’s right, hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive.

To learn more about BD visit

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