Job Description Summary

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.

Job Description Summary:

Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies. Prepares, or directs the preparation of, regulatory submissions. Identifies and communicates potential risks and mitigations associated with regulatory strategies. Monitors worldwide regulatory developments and communicates emerging opportunities/concerns. Coordinates interactions/negotiations with U.S. regulatory agencies and Notified Bodies. Participates in trade, professional, and standards development organizations. Reviews and approves labels, labeling, promotional materials, and clinical protocols/reports. Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions. Support International Registrations as it relates to product changes and/or new product launches. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis. Hybrid in-office/remote position. The position does not require any national or international travel. The role allows for work to be performed on a hybrid schedule of 3 days in office in Franklin Lakes, NJ and 2 days remotely.

Qualifications:

Master’s degree in Regulatory Affairs, Computer Science, Engineering (any), Biology or Chemistry or related field of study and five (5) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Regulatory Affairs, Computer Science, Engineering (any), Biology or Chemistry or related field of study and five (5)years of experience, the employer will also accept a Bachelor’s degree in Regulatory Affairs, Computer Science, Engineering (any), Biology or Chemistry or related field of study and eight (8) years of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Preparation of EU Technical Files and Dossiers for product registration; preparation of US 510(k) or PMAs for product sale in the USA; management of quality documentation and records for regulated medical devices; preparation of annual reporting and supplements for submission to government authorities; and regulated medical device labeling requirements globally.

Salary offered for the position is: $140,000.00 - $215,200.00/year.

Primary Work Location:

1 Becton Drive, Franklin Lakes, NJ 07417.  Hybrid in-office/remote position.

The position does not require any national or international travel. The role allows for work to be performed on a hybrid schedule of 3 days in office in Franklin Lakes, NJ and 2 days remotely.

Additional Locations:

N/A

Work Shift:

Not Specified

To apply, mail resume to Becton, Dickinson and Company, Attn: BDHR – CS, 3750 Torrey View Ct, San Diego, CA 92130, OR submit a resume to https://nj.gov/labor/career-services/, OR submit a resume to https://bdx.wd1.myworkdayjobs.com/EXTERNAL_CAREER_SITE_USA. Must reference Job Title & Job Code: R-528700. EOE.

#DNPBD

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 sto