Associate Director Regulatory Affairs

Associate Director Of Regulatory Affairs

We are the makers of possible. 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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

Responsibilities

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.

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 science STEM 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. Must have 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 12 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 required.

Preferred Qualifications

Advanced degree, master's degree or higher preferred with a focus in a scientific discipline preferred.

Familiarity with Infusion Pump Systems preferred.

Regulatory Affairs Certification (RAC) preferred.

Project Management Certification preferred.

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.