BD Nogales Norte
Associate Director Regulatory Affairs
BD Nogales Norte, San Diego, California, United States, 92189
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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 billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description Summary
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, managing regulatory affairs submissions, handling existing product registrations including variations and renewals, interacting with global internal stakeholders as well as external consultants and service providers, and developing and maintaining documentation for compliance programs such as labeling, promotional material review, and other regulatory requirements. 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, with 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 optimally collaborate across departments and geographies Preferred Qualifications
Advanced degree, master’s degree or higher with a focus 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 because we believe it fosters creativity, innovation, and effective problem‑solving, which are 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 and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we 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. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers Equal Employment Opportunity
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 or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics. Seniority Level
Mid-Senior level Employment Type
Full-time Job Function
Legal Industries
Manufacturing Salary Range
San Diego Metropolitan Area $200,000.00–$240,000.00
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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, managing regulatory affairs submissions, handling existing product registrations including variations and renewals, interacting with global internal stakeholders as well as external consultants and service providers, and developing and maintaining documentation for compliance programs such as labeling, promotional material review, and other regulatory requirements. 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, with 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 optimally collaborate across departments and geographies Preferred Qualifications
Advanced degree, master’s degree or higher with a focus 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 because we believe it fosters creativity, innovation, and effective problem‑solving, which are 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 and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we 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. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers Equal Employment Opportunity
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 or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics. Seniority Level
Mid-Senior level Employment Type
Full-time Job Function
Legal Industries
Manufacturing Salary Range
San Diego Metropolitan Area $200,000.00–$240,000.00
#J-18808-Ljbffr