Associate Director Regulatory Affairs at BD San Diego, CA

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 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.

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.