BD
Associate Director Regulatory Affairs - Becton Dickinson
BD, San Diego, California, United States, 92189
Associate Director Regulatory Affairs - Becton Dickinson
Becton, Dickinson and Company (BD) is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and we believe that the human element across our global teams allows us to continually evolve. We support learning, growth, and the best version of ourselves.
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.
Education and Experience Required
Bachelor’s degree in science, STEM, or 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. 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.
Knowledge and Skills Required
Demonstrated interpersonal skills necessary to collaborate optimally across departments and geographies.
Preferred Qualifications
Advanced degree, master’s degree or higher in a scientific discipline.
Familiarity with infusion pump systems.
Regulatory Affairs Certification (RAC).
Project Management Certification.
Work Environment
Travel up to 20% domestically and internationally may be required.
At BD, we prioritize on‑site collaboration to foster creativity, innovation, and effective problem‑solving. Most roles require a minimum of 4 days of in‑office presence per week, with flexibility and work‑life balance as core values. For certain roles, employment is contingent upon the Company’s receipt of sufficient proof of full COVID‑19 vaccination; testing may be available or required, depending on location.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
#J-18808-Ljbffr
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.
Education and Experience Required
Bachelor’s degree in science, STEM, or 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. 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.
Knowledge and Skills Required
Demonstrated interpersonal skills necessary to collaborate optimally across departments and geographies.
Preferred Qualifications
Advanced degree, master’s degree or higher in a scientific discipline.
Familiarity with infusion pump systems.
Regulatory Affairs Certification (RAC).
Project Management Certification.
Work Environment
Travel up to 20% domestically and internationally may be required.
At BD, we prioritize on‑site collaboration to foster creativity, innovation, and effective problem‑solving. Most roles require a minimum of 4 days of in‑office presence per week, with flexibility and work‑life balance as core values. For certain roles, employment is contingent upon the Company’s receipt of sufficient proof of full COVID‑19 vaccination; testing may be available or required, depending on location.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
#J-18808-Ljbffr