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.
The 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), creating and executing regulatory strategy, change assessment, and completing high quality US and EU regulatory submissions per project plans.
Activities include but are not limited to the following:
Represents RA in new product development team(s). Responsible for completion of regulatory strategy, review and approval of design control related documents.
For changes to products and processes, conducts regulatory assessments, authors and maintains Letters to File, and tech files updates.
Writes and leads the completion of high quality 510(k)s and/or EU Technical Files (both IVDD and IVDR) with limited supervision.
Obtains FDA clearance of 510(k)s, and Notified Body’s approval of technical files, with desired claims, per project plan.
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.
Excellent project management, negotiation, communication (written and verbal) and interpersonal skills; ability to communicate and work in a diverse team environment; effective interactions with technical personnel (scientific and legal).
Excellent team skills with ability to influence others without authority.
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.
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.). 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.
Location = Preference would be a candidate in the San Jose area, but also open to remote candidates that could work pacific time zone hours.
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.
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 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.
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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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