Associate Director Regulatory Affairs

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

Knowledge and Skills required

Preferred qualifications

Work environment

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.

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