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BD (Becton, Dickinson and Company) Sr. RA Specialist - EU MDR Program (REMOTE Optional) in Warwick, Rhode Island

Job Description Summary

Job Description

This position will be working in the BD Interventional Surgery (BDIS) Business Unit supporting programs focused on transitioning implantable and/or resorbable medical devices to the new European Medical Device Regulation. Under the guidance of the Director of Regulatory Affairs, the position will provide technical and administrative regulatory support to the BDIS EU MDR Compliance Program to ensure timely and effective approvals of medical device Technical Documents to the new regulation.

This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2023.

Responsibilities:

  • Supports the BDIS Regulatory Affairs lead of the EU MDR Compliance Program in tracking and ensuring progress of certification plans where regulatory affairs involvement is required.

  • Develops new or provide input to existing metrics to appropriately monitor and communicate project statuses for the BDIS Regulatory Affairs group.

  • Assists in organizing and communicating key RA Strategies and impacts of EU MDR program to BDIS Regulatory Affairs team.

  • Coordinates, attends, and generates meeting minutes for BDIS Regulatory Affairs team.

  • Assists BDIS RA specialists in EU MDR Technical Document creation, submission, and during notified body reviews.

  • Works with cross functional teams to deliver supporting documents necessary for Technical Document submissions or Technical File maintenance.

  • Helps maintain licenses, manage legacy technical files updates (removal of SKU’s as they transition to MDR).

  • Assess global impacts and support registrations, where required, as a result of EU MDR changes.

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

Qualifications

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

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

  • Knowledge and experience with European Union medical device regulatory requirements (MDD and MDR) is required .

  • Knowledge and experience with regulatory requirements for medical devices in the US (PMA’s and 510(k)’s).

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

  • 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.

  • Ability to work as a project leader and influence others

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.

EU MDR

#LI-PRO

Primary Work LocationUSA 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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