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.
This position is responsible for managing the various regulatory activities for new and existing medical devices and/or pharmaceuticals. Examples include, but are not limited to.
Write domestic device and drug regulatory submissions including PMA, 510(k), NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses.
Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes.
Review Labeling and Advertising and Promotional materials for compliance to internal procedures.
Manage and maintain the drug and device registrations and listings (FURLS/DURLS) system.
Support the quality system and internal/external audits.
Excellent organizational and communications skills.
Candidate should be able to work independently, support project teams, to address and communicate problems and complex issues in a concise and effective manner , to manage multiple projects/tasks simultaneously, and effectively manage and prioritize regulatory submission projects.
Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required.
Experience navigating FDA databases required.
Experience with EU MDR preferred. Experience with electronic submissions and ERP systems is preferred.
Minimum BS required in science, such as Chemistry, Biology, Microbiology, or engineering. Masters Preferred.
Strong attention to detail and Excellent organizational skills
History of successful regulatory submissions
Project management of regulatory submissions with minimal guidance
Effective verbal and written presentation and communication skills Comprehensive coordination and compilation of documentation
Minimum of 3 years' experience in Regulatory Affairs in Medical Devices and/or Pharmaceuticals. A combination of both preferred.
Minimum of 3 years experience working with the FDA CDRH and/or CDER
Strong working knowledge of US and International regulations and guidance, such as 21 CFR 820, ISO 13485, ICH guidelines and 21 CFR 210/211. Internal auditing experience a plus.
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.
Primary Work LocationUSA IL - Vernon Hills
Additional LocationsUSA RI - Warwick
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.
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