Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
About the role:
The Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit focusing on self-injection devices and safety systems. Under the guidance of the Manager or Staff RA Specialist, the position will provide technical and administrative regulatory support to ensure timely new product launches or product changes in U.S. and global regions. Additionally, this position will provide regulatory support to marketed products and monitor regulatory intelligence impacting product compliance.
Key responsibilities will include:
- Support for Pharmaceutical Systems regulatory projects in a continuous effort to adapt the activity as closely as possible to the needs of the pharmaceutical industry
- Coordinate and prepare new regulatory documents (master file, technical file) and updates in a timely manner
- Coordinate and collect specific product or technical information with R&D, QA, RA, Medical Affairs and other applicable departments as necessary to support regulatory documents
- Support regulatory documents and registrations as it related to product changes, new product launches and/or product renewals
- Support RA with customer and technical inquiries (post market)
- Regulatory intelligence for GPDS support
- Perform other tasks as assigned
To be successful in this role, you require
- Knowledge of regulations for pharmaceutical drug products, medical devices or drug-device combination products
- Understanding of product development cycle, change control, quality systems
- Ability to adapt and respond quickly in a constantly evolving and often ambiguous environment
- Strong team spirit, integrity mentality
- Strong customer centric mentality (internal and external)
Education and experience required:
- Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
- B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry).
- Minimum 3 years of directly related professional experience (Regulatory, Quality, Compliance)
- RAPS certification a plus.
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
- # LI-PRO
Primary Work LocationUSA NJ - Franklin Lakes
Work ShiftUS BD 830am-5pm FLakes Core Hours (United States of America)
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
Staff Regulatory Affairs Specialist
I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.
Global Regulatory Operations Labeling Specialist
I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.
Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist