BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Staff Regulatory Specialist, Product Development REMOTE in San Diego, California

Job Description Summary

Job Description

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. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 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 has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

Functional/Organizational 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 carry out related regulatory affairs activities, such as development, execution and management of submission strategies, development and review of procedures and systems designed to support the regulatory processes, and address global regulatory requirements as well as the objectives of the business.

Position Summary

This position is responsible for support of a variety of product development related regulatory activities and projects, and/or personnel. This position will provide guidance 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.

Key responsibilities:

  • Coordinate, prepare, and execute FDA Premarket Notification (510(k)) submissions in a timely manner with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.). Act as liaison with FDA regarding product submissions and clearance.

  • Prepare submission strategies for new products and proposed device modifications.

  • Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle. Coordinate cross-functional team inputs for regulatory submissions.

  • Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.

  • Proactively lead regulatory efforts required to comply with new regulations and requirements.

  • Provide RA leadership within the RA organization.

  • Review protocols and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.

  • Develop or provide input to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

  • Work cross-functionally and lead cross-functional teams to in preparation of product submissions

  • Remain current on standards, guidances, and regulations affecting BD; assess and communicate potential impact.

  • Identify ways to improve the efficiency of current work process and execute them.

  • Performs other duties and assignments as required.

Professional Skills & Key Competencies

  • Ability to read, analyze, and interpret, and review scientific, technical, and regulatory literature and documents.

  • Excellent verbal and written communication skills; ability to effectively communicate information to peers and all levels of management.

  • Ability to identify and define risks and problems and communicate mitigations and solutions both verbally and in writing to a variety of audiences.

  • Sound understanding of 21 CFR 820, design control processes, FDA regulations, and medical device guidance documents, standards, and requirements.

  • Ability to manage multiple, often competing priorities, meet deadlines, and prioritize/organize complex information.

  • Excellent interpersonal and analytical skills.

Minimum Qualifications:

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

  • Minimum 5 years of strong Regulatory Affairs experience in the medical device industry; prior experience working with software-driven medical devices strongly preferred.

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.

Certifications

RAC desired.

Any Additional Information

REMOTE or San Diego, CA based

BD and Covid-19: To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location, but is temporarily remote-based due to Covid-19. Any offer of employment is contingent upon the candidate reporting to work at the site if/when associates are requested to return to the workplace.

If Remote - Ability to travel up to 30% (when travel is able to resume safely)

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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