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
This position will be working in BD Interventional Surgical Devices Business unit on Implantable and Absorbable devices. Under the mentorship of the Director of Regulatory Affairs, this position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. and Europe. This position also will be executing on related regulatory affairs activities, such as development, execution and management of procedures and systems crafted to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. The incumbent will perform essential duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates
- Coordinate, prepare, and execute applications and supplements to the US FDA with a focus on Class III devices including Pre-Sub, IDE, PMA, and de Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.
- Assess necessity for reporting changes to FDA for proposed device modifications. Prepare robust reporting justifications for changes that do not require supplements or notices.
- Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.).
- Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements and providing measurable regulatory mentorship throughout the product development cycle prior to regulatory submission.
- Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.
- Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
- Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance.
- Review clinical and human factors protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
- Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Coordinate and respond to requests for product information, and questionnaires requested by customers.
- Remains current on regulations affecting BD products and keep the relevant team and supervisors advised about potential impact.
- Identify ways to improve the efficiency of current work process and execute them.
- Carry out the above tasks without supervision.
- B.S. degree in a technical field (e.g., computer science, engineering, bioengineering, biology, chemistry). Advanced degree preferred.
- Minimum 5 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies.
- Proven ability to resolve problems and to make appropriate regulatory decisions under pressure.
- Proven success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE) to FDA and other global regulatory agencies; preferably CDRH and preferably PMA
- Experience in negotiating with FDA personnel in the device (CDRH).
- International product registration experience preferred.
Knowledge, Skills, and Abilities:
- Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
- Strong communication (written, oral) and project management skills.
- Must be able to balance multiple tasks with attention to detail with limited supervision.
- Demonstrated global perspective, customer focus, cross-functional teamwork and partnership skills.
- Extensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA mentorship documents, Good Clinical Practice standards, Good Laboratory Practice regulations.
- Extensive knowledge of regulatory requirements for absorbable and implantable devices.
- Extensive knowledge in new product regulatory strategies.
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 RI - Warwick
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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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