BD (Becton, Dickinson and Company) Sr. Regulatory Affairs Specialist in San Jose, California
Job Description Summary
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), 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.
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.
Represents RA in new product development team(s). Responsible for completion of RA strategy, review and approval of design control related documents.
Writes and owns the completion of high quality 510(k)s and/or Technical Files with limited supervision.
Acquires 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. Minimum Qualifications:
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 balance multiple tasks and to prioritize and schedule work to meet business needs.
Ability to identify areas of concern in moderately sophisticated projects and manage changes.
Proven organizational and planning skills, including process savvy, driven, focused and working towards results
Excellent team skills with ability to influence others without authority.
Excellent interpersonal skills, ability to communicate and work in a team with varied strengths' environment; effective interactions with technical personnel (scientific and legal). This includes excellent written and verbal communication skills
Ability to write high quality submission documentation
Digital 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.
Why join us?
A career at BD means joining a team that values your points of view and contributions and that encourages 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 hardworking and committed to encouraging an expansive, growth-centered, and exciting work environment. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is crafted 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 Location
USA CA - San Jose