BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Staff Regulatory Affairs Specialist (Remote Optional) in San Jose, California

Job Description Summary

Job Description

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. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to accurately detect disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics.

BD Biosciences, as part of BD, is an industry leader in flow cytometry area. We are recruiting recruiting for a Staff Regulatory Affairs Specialist to join our IVD and Companion Diagnostics (CDx) new product development team. We seek an innovative and highly motivated leader to develop and lead the implementation of regulatory strategy to expedite the availability of new technology to market, to empower scientists and doctors to transform lives. The role will provide the successful candidate with the opportunity to work in a highly matrixed and collaborative environment

Job Responsibilities:

Provides regulatory leadership to IVD and Companion Diagnostics (CDx) product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.

Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for global submissions.

Leads and prepares regulatory submissions, such as US PMA, 510(k) submissions, pre-submission, and EU IVDR Technical Documentation, and leads submission process through clearance/approval.

Coordinates interactions/negotiations with U.S. and EU regulatory agencies.

Works with business and cross-functional team to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans.

Reviews and approves labels, labeling, and promotional materials.

Reviews product design and change documentation, performs regulatory assessments, and implements required regulatory actions.

Reviews analytical and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.

Responsible for writing and updating standard operating procedures (SOP) and work instructions (WI).

Identifies and communicates potential risks and mitigations associated with regulatory strategies.

Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

Conducts impact assessment of changing regulations and guidance and participates in advocacy.

Mentor junior staff of regulatory professionals and conduct training on regulatory subject.

Provides support to Staff RA Specialist, and performs other related duties and assignments as required.

Minimum Qualifications:​

Bachelor's degree required, preferred in science and engineering

Minimum 5 years’ experience in regulatory affairs in the device/diagnostic industry. Demonstrated experience in authoring FDA 510(k), leading pre-submissions, and interact with FDA to obtain clearance. Experience with PMA, IVDR/MDR and IVD experience is a plus.

Working knowledge of US and EU In Vitro Diagnostic or Medical Device Regulatory requirements.

Demonstrated project management, negotiation, and communication (written and oral) skills to all levels within the organization and external to the organization.

Demonstrated ability to interpret and implement new regulations and guidance.

Demonstrated ability to prioritize challenging priorities and deadlines, and organize complex information

Demonstrated analytical thinking to comprehend and analyze an issue, and resolve problem.

Location = Preference would be a candidate in the San Jose area, but also open to remote candidates that could work pacific time zone hours.

For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. 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.

#LI-PRO

Primary Work Location

USA CA - San Jose

Additional Locations

USA CA - San Diego (BDB)

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

DirectEmployers