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BD (Becton, Dickinson and Company) Regulatory Affairs Project Manager (Pacific Time Zone 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. 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.

Regulatory Affairs Project Manager is responsible for providing regulatory leadership in product development program teams by providing regulatory guidance throughout the product development cycle. This includes creating and executing regulatory strategies, the preparation of regulatory submissions required to market new or modified medical devices in the US, EU, and other geographies, and related regulatory affairs activities, such as development and execution of procedures and systems designed to ensure that the product development process, including clinical, non-clinical, and performance evaluation studies, addresses all regulatory requirements as well as the objectives of the business. This position requires to collaborate with other functions (R&D, Quality, Operations, etc.).

Job Responsibilities:

  • Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.

  • 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.

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

  • Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies.

  • Leads and prepares regulatory submissions, such as US 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.

  • 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 Sr. RA manager, and performs other related duties and assignments as required.

Minimum Qualifications:​

  • Bachelor's degree required, strongly preferred in science and engineering

  • Minimum 5 years’ experience in regulatory affairs in the device/diagnostic industry. IVDR/MDR and IVD experience a plus.

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

  • Demonstrated experience in authoring FDA 510(k), leading pre-submission meetings, and interact with FDA to obtain clearance. Experience in authoring Tech files and working with Notified Bodies to obtain approval is a plus.

  • 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 competing 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.

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

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