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 SummaryThe Sr. Regulatory Affairs Specialist is responsible for support of a variety of regulatory activities and projects with oversight from senior regulatory staff. The focus is on representing RA in new product development core team(s), completing high quality US 510(k) and EU technical files (both IVDD and IVDR) per project plan, and obtaining timely 510(k) clearance for U.S., and Notified body approval of tech files for EU.
Activities include but are not limited to the following:
- Represents RA in new product development team(s). Responsible for completion of RA strategy, review and approval of design control related documents.
- Writes and leads the completion of high quality 510(k)s and/or Technical Files with limited supervision.
- Obtains FDA clearance of 510(k)s, and Notified Body’s approval of technical files, with desired claims, per project plan.
- For changes to products and processes, conducts regulatory assessments, authors and maintains Letters to File, and tech files updates.
- Works will entail problems of moderate complexity and diverse scope, including data analysis and ownership of task execution and completion.
- Assists in implementing department procedures and maintaining regulatory requirements.
- Provides support to Sr. RA manager, and performs other related duties and assignments as required.
- 3 years of U.S. 510(k) and EU technical file experience for IVD instruments, software, and/or reagents required.
- Familiar and or experience with regulatory requirements for IVD manufacturers such as design control requirements, listings, establishment registrations, etc.
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving
- Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
- Ability to identify areas of concern in moderately complex projects and manage changes.
- Demonstrated organizational and planning skills, including process savvy, action oriented, focused urgency and driving for results
- Excellent team skills with ability to influence others without authority.
- Excellent interpersonal skills, ability to communicate and work in a diverse team environment; effective interactions with technical personnel (scientific and legal). This includes excellent written and verbal communication skills
- Ability to write high quality submission documentation
- Computer literacy (SAP, Microsoft Word / Excel / PowerPoint)
- Detail oriented, with emphasis on accuracy and completeness
Education and Experience:
- B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.). Masters preferred. RAC Certification a plus.
- A Minimum of 3 years’ experience working in an U.S. FDA/ or ISO regulated environment.
- EU IVDR experience a plus.
- Flow cytometer experience a plus.
Primary Work LocationUSA CA - San Jose
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.
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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