Job Description

Job Title: Regulatory Affairs Associate Director

Job Summary: As Regulatory Affairs Associate Director, you will lead RA team members involved in device project activities and new product development within the Advanced Drug Development Delivery platform. You will serve as the primary FDA contact in the US and oversee regulatory activities for the new product portfolio, focusing on standards related to new product design. Associates are required to be onsite at our Franklin Lakes, NJ headquarters Monday through Thursday, with optional work from home on Fridays.

About BD: We are the makers of possible . BD is one of the largest global medical technology companies, committed to advancing health through innovative solutions. We foster an environment that supports learning, growth, and excellence, encouraging our team to be a maker of possible .

Primary Responsibilities:

1. Lead and support the RA team, fostering a culture of empowerment and development.
2. Develop and execute regulatory strategies to ensure compliance of Pharmaceutical Systems (PS) products with current regulations, enabling successful new product development.
3. Manage promotional material reviews and ensure external communications align with regulatory requirements.
4. Educate and train cross-functional teams on EU and FDA regulatory requirements pertinent to pharmaceutical systems and customers.
5. Maintain appropriate registrations with regulatory authorities and develop responses for regulatory inquiries, preparing the team for interactions with agencies.

About You:

1. B.S. or B.A. in a technical field (engineering, biology, chemistry, pharmacy); advanced degree and medical training preferred.
2. At least 8 years of regulatory affairs experience in the pharmaceutical or medical device industries, with expertise in drug-device combination products, regulatory submissions, and interactions with authorities.
3. Proven leadership skills with the ability to drive change and inspire teams.
4. Ability to operate effectively in a matrix environment and build strong relationships.
5. Comprehensive knowledge of U.S. medical device regulations (FDA), clinical and laboratory standards, and quality system regulations.

Workplace Policy: BD emphasizes on-site collaboration, requiring a minimum of 4 days per week in the office to foster innovation and teamwork. Flexible arrangements are available for certain roles and will be specified in the job posting.

Employment may be contingent upon proof of COVID-19 vaccination or testing, in accordance with BD’s policies and applicable laws.

Why Join Us?

Join a team that values your contributions and supports your growth. At BD, you can bring your authentic self to work, contribute to meaningful health innovations, and thrive in a culture of accountability, learning, and purpose.

Learn more at

Becton, Dickinson, and Company is an Equal Opportunity Employer, welcoming applicants regardless of race, color, religion, age, sex, sexual orientation, gender identity, disability, veteran status, and other protected characteristics.

Job Tags

Similar Jobs