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BD (Becton, Dickinson and Company) Staff Regulatory Affairs Specialist, Labeling and Ad/Promo (REMOTE) in San Diego, California

Job Description SummaryPosition Summary

This position will be working in BD-Medication Management Solutions on Regulatory Affairs projects that may span the Infusion, Dispensing and Technology Solutions portfolios. This role will be providing regulatory expertise for advertising and promotion of BD products, implementing UDI and related global requirements, reviewing marketing materials that are impacted by advertising and promotion regulations, becoming an expert on product labeling including all documentation that ships with the device as well as labeling that adheres to the device. This role will partner with Marketing, Legal, Engineering, Technical Writing, Human Factors, and various other departments as required.

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.

BD Medical

BD Medical is among the world's leading suppliers of medical devices and a leading innovator in injection- and infusion-based drug delivery. We’re focused on providing innovative solutions to reduce the spread of infection, improve diabetes treatment and advance drug delivery.

Medication Management Solutions

With our technical capabilities, the Medication Management Solutions (MMS) team are able to manage multiple systems and our operational capabilities enable us to have medications available when and where needed, reducing inefficiency and waste for nursing and pharmacy teams.

As Staff Regulatory Affairs Specialist you will support of a variety of product development related regulatory activities and projects, and/or personnel. This position will provide mentorship to project teams as well as other RA teams to help MMS achieve its business goals within the scope of this position. This role will develop and contribute to regulatory affairs strategy development, exhibit strong cross-functional influencing skills, lead regulatory initiatives, and provide regulatory expertise to peers and business partners.

In this role you will be responsible for:

  • Coordinate, review and approve labeling and promotional materials in relation to premarket applications to FDA, EU and international regulators with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.) Act as liaison with FDA, notified bodies, and international regulators regarding labeling.

  • Review substantiation for proposed device labeling modifications. Prepare robust non-filing justifications for labeling changes that do not require a 510(k) submission.

  • Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory labeling requirements, and providing impactful regulatory mentorship throughout the product development cycle prior to regulatory submission.

  • Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to partners in relation to labeling.

  • Proactively lead regulatory efforts required to align with new labeling regulations and requirements; i.e., EU MDR, MDSAP.

  • Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance.

  • Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable labeling regulations and standards.

  • Represent BD in relevant external trade organizations and regulatory standard's development as vital to support BD’s continuous product development and compliance efforts.

To be successful in this role, we require:
  • Sound understanding of design control processes, FDA, and global regulations and standards.

  • Ability to lead multiple projects, meet deadlines, prioritize/coordinate complex information, excellent interpersonal, communication and analytical skills.

Education and experience required:

  • Bachelor’s degree, preferably master’s degree in life sciences.

  • Minimum 5 years of strong Regulatory Affairs experience in a medical device company, with strong expertise in labeling and advertising/promotional materials.

Desired/Additional Skills & Knowledge:
  • Familiarity with infusion pumps, safety assurance cases, human factors, and cybersecurity.

  • Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle.

  • Regulatory Affairs Certificate desired.

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Why join us?

A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you 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.

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 LocationUSA CA - San Diego TC Bldg C&D

Additional Locations

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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