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BD (Becton, Dickinson and Company) Staff Regulatory Affairs Specialist (Remote optional) in California

Job Description Summary

This position will be working in the BD Interventional Surgery Business Unit on implantable and absorbable devices. Under the mentorship of the Director of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in both the U.S. and Europe. The incumbent should have demonstrated leadership and success working in cross-functional teams and will perform essential duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates.

Job Description

This position will be working in the BD Interventional Surgery Business Unit on implantable and absorbable devices. Under the mentorship of the Director of Regulatory Affairs, they are responsible for the development of sophisticated global regulatory strategies and preparation of regulatory submissions required to market medical devices in both the U.S. and Europe. The incumbent should have proven leadership and success working in cross-functional teams and will perform crucial duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates.

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.

Responsibilities:

  • Lead cross functional team while demonstrating leadership in preparing and executing submissions to the US FDA with a focus on innovative Class II and III devices including Pre-Submissions, IDE, PMA, and De Novo submissions. Act as liaison with FDA regarding product submissions.

  • Represents RA and demonstrates leadership in product development team(s). Responsible for completion of regulatory strategies, review and approval of design control-related documents.

  • Ensures that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, and scientifically based.

  • Implement company and departmental goals, objectives, and implement requirements of quality work. Ensure RA department processes and procedures related to regulatory responsibilities are compliant, current and efficient.

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

  • Ability to be effective in complex projects with ambiguity and/or rapid change.

  • Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential product or process impacts.

  • Represents BD Surgery in corporate/segment working groups

  • Provides regulatory support during internal/external audits and inspections.

Qualifications:

  • B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science). B.A. or B.S. in other field acceptable with appropriate level of experience.

  • Minimum 4-5 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies.

Knowledge, Skills, and Abilities:

  • Proficient in using Microsoft Word, Excel, PowerPoint, and Project.

  • Must be able to balance multiple tasks with attention to detail with limited supervision.

  • Proven global perspective, customer focus, cross-functional collaboration and teamwork skills.

  • Proven ability to resolve problems and to make appropriate regulatory decisions.

  • Excellent oral and written communications skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.

  • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, including analytical problem solving.

  • Extensive knowledge of US medical device regulations, 21 CFR 820 Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.

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.

PDN

Primary Work Location

USA CA – Brea

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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