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BD (Becton, Dickinson and Company) Senior Regulatory Affairs Specialist (International IVD Registration)(remote) in San Diego, 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

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.

The Senior Regulatory Affairs Specialist will be responsible for partnering in the preparation and approval of regulatory submissions of in vitro diagnostic devices worldwide. The Senior Regulatory Affairs Specialist will execute regulatory project timelines and manage the processes and systems designed to ensure that all regulatory requirements are met for a location change (re-location) of a production facility.

Job Responsibilities:

  • Leads collecting, compiling, and analyzing, country specific regulatory requirements

  • Drives international registrations according to project plan

  • Reviews and approves technical documentation to ensure required information and data for regulatory submissions are included.

  • Prepares and/or compiles information required by international regulatory associates to register or maintain registration of products in international regions.

  • Collaborates with cross-functional teams for preparation of additional data/information requested by notified body/ regulatory agencies and prepares appropriate responses to all requests.

  • Ensures submission tasks related to Assessment of Change Requirements (ACR) are completed

  • Compiles and communicates Regulatory impact assessments, submission & approval status world-wide to Supply Chain to ensure regulatory compliance and business continuity

  • Assists in developing, maintaining, reporting regulatory submission & approval status dashboard & metrics.

  • Obtains Regulatory Certificates such as CFGs, FSCs

Education and Experience:

  • Bachelor's degree in health science or life science field (biology, chemistry, bio-engineering, microbiology) or related field.

  • Minimum 3 years’ experience in the device/diagnostic, biologic and/or pharmaceutical industry in regulatory affairs

  • Experience with several international countries RA product registration/assessment (eg. China, Brazil, India, Philippines, South Korea, APAC, EMEA etc)

  • Proven ability to interpret in vitro diagnostic device (IVD) regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR); and European Quality System standards

  • Lead, influence and apply feedback from cross functional teams (BDB, Regional and Country RA associates, Regulatory bodies).

  • Digital literacy (SAP, Excel, PowerPoint, Access, Agile, Regulatory e-Systems)

  • Project management experience highly preferred; experience with prioritizing multiple tasks and driving results.

Work Environment

  • Remote (USA - home) is an option for this role

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 Diego (BDB)

Additional Locations

USA CA - San Diego (Diagnostic Sys.), USA CA - San Jose, USA CA - San Jose (Reagents)

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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