Job Description Summary

As Regulatory Affairs Associate Director, you will be responsible for leading RA team members involved in device project activities and new product development in Advanced Drug Development Delivery platform. You will be the primary FDA contact in the US. You will oversee regulatory activities for the new product portfolio, primarily focusing on assessing, understanding, and cross-functionally building the deployment and impact of standards related to new product design. Associates will be required to be onsite in our Franklin Lakes, NJ headquarters Monday through Thursday. Associates may work at home on Friday.

Job Description

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 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. 

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. 

Primary Responsibilities:

• Lead team ensuring the right balance between support and empowerment as well as the right level of development and coaching to support cultural change and position RA team as solution providers.

• Own regulatory strategy to ensure all Pharmaceutical Systems (PS) products meet the latest regulatory requirements to ensure new product developments is successful.

• Own promotional material review activities and business specific procedures; accountable for alignment of external communication and claims to regulatory requirements.

• Educate and train PS cross-functional teams on EU and FDA requirements applicable both to pharmaceutical systems and our customers, on an ongoing basis, to ensure regulatory framework understanding.

• Accountable for appropriate registrations with the Competent Authorities as well as regular updates; develop response strategies for regulatory questions and prepare team for interacting and negotiating with regulatory agencies if necessary.

About you:

• B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry, pharmacy.) Advanced degree preferred; medical training preferred.

• Minimum 8 years of regulatory affairs experience within the pharmaceutical or medical device industries, ideally with expertise in drug-device combination products; experience in regulatory and/or R&D, quality engineering functions, strong knowledge in design control and product development, and multiple submission dossier preparation and interaction with regulatory authorities is required.

• Demonstrated supervisory and leadership skills; able to drive change and inspire associates.

• Ability to navigate in a matrix environment and build solid relationships enabling RA to be a business partner and a strong and respected voice.

• Comprehensive knowledge of U.S. medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations.

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

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.

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

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