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BD (Becton, Dickinson and Company) Regulatory Affairs Specialist (Remote Optional) 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 guidance 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.

Responsibilities:

  • Coordinate, prepare, and execute supplements and required reports to the US FDA with a focus on Class III devices including 30 Day Notices, 180 day supplements, annual reports in a timely manner. Act as liaison with FDA in support of these submissions and facilitate the building of responses to any requests for information from the FDA related to these 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.

  • Assist Product Development and Quality Assurance in planning testing that will ultimately be used in regulatory submissions.

  • 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.).

  • Assist in the review and approval product labeling, promotional, and advertising materials to ensure regulatory compliance.

  • assist in updates to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

  • 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.

Qualifications

  • B.S. or equivalent with emphasis on material science or mechanical engineering. Professional certifications preferred.

  • 1-2 years of experience in medical devices required (must have experience in one of the following areas in medical devices: Regulatory Affairs, Quality or R&D).

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

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

  • Working knowledge of statistics and electronic documentation and information systems.

  • Ability and desire to travel as needed.

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.

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.

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Primary Work LocationUSA RI - Warwick

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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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