BD Mexico
Job Description Summary
We are the makers of possible.
Job Description 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.
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.
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 STEM science or engineering
Minimum 10 years of relevant experience in the medical device industry, 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 optimally collaborate across departments and geographies.
Preferred qualifications
Advanced degree, master’s degree or higher preferred with a focus in a scientific discipline.
Familiarity with Infusion Pump Systems.
Regulatory Affairs Certification (RAC) preferred.
Project Management Certification preferred.
Work environment
Travel up to 20% domestically and internationally may be required.
Work Schedule Minimum 4 days of in-office presence per week. Remote or field-based positions may have different workplace arrangements.
COVID-19 Vaccination Employment may be contingent upon proof of full vaccination against COVID-19 in some locations.
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, do what’s right, hold each other accountable, and learn and improve every day.
Location Primary Work Location: USA, CA - San Diego TC Building C&D.
Equal Opportunity Employer 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.
#J-18808-Ljbffr
Job Description 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.
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.
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 STEM science or engineering
Minimum 10 years of relevant experience in the medical device industry, 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 optimally collaborate across departments and geographies.
Preferred qualifications
Advanced degree, master’s degree or higher preferred with a focus in a scientific discipline.
Familiarity with Infusion Pump Systems.
Regulatory Affairs Certification (RAC) preferred.
Project Management Certification preferred.
Work environment
Travel up to 20% domestically and internationally may be required.
Work Schedule Minimum 4 days of in-office presence per week. Remote or field-based positions may have different workplace arrangements.
COVID-19 Vaccination Employment may be contingent upon proof of full vaccination against COVID-19 in some locations.
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, do what’s right, hold each other accountable, and learn and improve every day.
Location Primary Work Location: USA, CA - San Diego TC Building C&D.
Equal Opportunity Employer 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.
#J-18808-Ljbffr