BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Staff Regulatory Affairs Specialist, Change Management [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 submissions, 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 regulatory activities and projects, and/or personnel. The primary focus of this position is assessing changes to commercialized product to determine the worldwide regulatory impact of the change, preparing documentation to support the regulatory pathway for the change, and communicating the change impact to affected organizations across BD. This position may provide Regulatory guidance to project teams, Operations, and/or Sales in relation to the changes. This position requires staying abreast of global regulations to help MMS achieve its business goals within the scope of this position, contributes to regulatory affairs strategy development, and exhibits strong cross functional influencing skills.

Key responsibilities:

  • Review, approve, and document regulatory changes to commercialized devices.Prepare robust non-filing justifications for changes that do not require a submission.

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

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

  • Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance.

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

  • Work cross-functionally across multiple departments to communicate change impact.

  • Remain current on standards and regulations affecting BD products and communicate and incorporate required changes.

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

  • Performs other duties and assignments as required.

Professional Skills & Key Competencies

  • Read, analyze, and interpret, and review scientific, technical, and regulatory literature and documents.

  • Effectively communicate information to peers and all levels of management.

  • Translate regulations and guidelines into terms that other functions can understand and apply.

  • Define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences.

  • Solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.

  • Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.

  • Strong influencing skills. Establishes process and provides expertise for a specific area.

  • May supervise professional level staff.

Minimum Qualifications:

  • Bachelor’s degree required (Master’s degree in life sciences field preferred)

  • Minimum 5 years of strong Regulatory Affairs experience in the medical device industry.

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

  • Sound understanding of design control processes, FDA, and global regulations and standards.

  • Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.

  • Excellent interpersonal, communication and analytical skills.

  • Knowledge of software and instrument design regulations and standards.

Desired/Additional Skills & Knowledge:

Familiarity with infusion pumps, safety assurance cases, human factors, and cybersecurity.

Certifications

RAC desired.

Any Additional Information

REMOTE or San Diego, CA based

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-OPS

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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