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:
Assessing necessity for reporting changes to FDA/Notified Body for proposed device modifications. Preparing robust reporting justifications for changes that do not require supplements or notices. Sending notifications of change to EU Notified Body as required. Collaborating with international regulatory associates to assess necessity for reporting changes to global regulatory authorities for device modifications. Identifying and communicating appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders. Providing cross-functional support for regulatory submissions and compliance including review and approval of product labeling, promotional, and advertising materials to ensure regulatory compliance. Writing and updating standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. Maintaining regulatory databases/systems for key regulatory data. Identifying and communicating appropriately quantified risks and mitigations associated with global regulatory strategies to cross-functional collaborators. Providing regulatory support during internal/external audits and inspections. 100% telecommuting role. Reports to company headquarters in Franklin Lakes, NJ. Can work remotely or telecommute.
Qualifications:
Master’s degree in Health Science, Life Science, Regulatory Affairs (any), Biology, Chemistry, Engineering (any) or related field of study and two (2) 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 Biology, Chemistry, Engineering (any) or related field of study and two (2) years of experience, the employer will also accept a Bachelor’s degree in Health Science, Life Science, Regulatory Affairs (any), Biology, Chemistry, Engineering (any) or related field of study and five (5) years of work experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical devices; International product registration experience; US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards and Good Laboratory Practice regulations; Hazardous materials management; 510(k), - Quality System Regulation, and working knowledge of standards and FDA guidances; and All material related regulatory requirements (Prop 65, CONEG, DOT, IATA, IMO, and OSHA) in the US, Europe and Canada.
Salary offered for the position is: $111,925.00 - $118,600.00/year.
Primary Work Location:
1 Becton Drive, Franklin Lakes, NJ 07417. 100% telecommuting role. Reports to company headquarters in Franklin Lakes, NJ. Can work remotely or telecommute.
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-502018. 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 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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
Work Shift
