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BD (Becton, Dickinson and Company) Senior Regulatory Affairs Specialist in Warwick, Rhode Island

Job Description Summary

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, the position will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in U.S. and global regions. Additionally, the position will provide regulatory support to marketed products and ensure company's regulatory compliance status.

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:

  • Coordinate, prepare, and execute supplements and required reports to the US FDA with a focus on Class III devices including Pre-Sub, IDE, PMA, and de Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions.

  • Assess necessity for reporting changes to FDA for proposed device modifications. Prepare robust reporting justifications for changes that do not require supplements or notices.

  • Coordinate and prepare technical files for submissions to notified bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.).

  • Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements and providing measurable 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 stakeholders.

  • 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 regulations and standards.

  • Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.

  • Coordinate and respond to requests for product information, and questionnaires requested by customers.

  • Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential impact.

  • Carry out the above tasks with minimal supervision.

Qualifications:

  • B.S. degree in a technical field (e.g., computer science, engineering, bioengineering, biology, chemistry). Advanced degree preferred.

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

  • Knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers).

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

  • Proven success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE) to FDA and other global regulatory agencies; preferably CDRH and preferably PMA

  • Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.

Knowledge, Skills, and Abilities:

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

  • Strong communication (written, oral) and project management skills.

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

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

  • Comprehensive 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.

  • Comprehensive knowledge of regulatory requirements for absorbable and implantable devices.

  • Comprehensive knowledge in new product regulatory strategies.

For most roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In limited circumstances, 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.

Primary Work Location

USA RI - Warwick

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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