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Overview

Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health. At BD, you can make a true difference of one.

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Success Profile

What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.

  • Analytical
  • Collaborative
  • Communicator
  • Persuasive
  • Problem-solver
  • Skilled presenter

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A New Era in Healthcare

The complementary nature of BD and CareFusion capabilities make the new, combined company more relevant than ever before. It’s not just the solutions we offer, It’s also where we offer them. The global reach of the combined company can offer new solutions around the world.

Quote

Brian Carney, Staff RA Specialist, BD, Surgical

"The team at BD was exceptionally welcoming and courteous upon arrival on my first day. I was immensely impressed with the passion of my project team members. Positive energy here is contagious… I very much look forward to the coming years with the BD team!"

Robin Cassell, Global Regulatory Operations Labeling Specialist

"I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job."

Nikita A Mahendra Kumar, Senior Regulatory Affairs Specialist, Medication Delivery Solutions

"I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on."

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Benefits

  • Healthcare

  • Healthcare FSA

  • 401(k) / Retirement Plans

  • Employer Matching

  • Tutition Reimbursement

  • Paid Time Off

  • Location

  • Collaborative Culture

  • Compensation

  • Awards & Recognition

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Responsibilities

Job ID R-352411 Date posted 11/08/2019

Job Description Summary

Job Description

The Sr. Regulatory Affairs Specialist will be responsible for the preparation of regulatory submissions in accordance with EU IVDR and for related activities such as development of new procedures, performance evaluation plan and report and training functional team members on the new requirements. This position requires candidate to collaborate with other functions (R&D, Quality, Operations) and external consultants. Experience in project management is preferred.

Job responsibilities:

  • Understand and interpret EU in vitro diagnostic device (IVD) regulatory requirements.

  • Draft and prepare product technical files compliant to EU IVDR.

  • Coordinate and project manage the preparation of technical files by external consultants.

  • Represent RA in IVDR core team and identify regulatory activities for project schedule.

  • Interface with Notified body to obtain approval of Technical Files.

  • Coordinate the preparation of additional data/information requested by notified body and prepares appropriate responses to all such requests.

  • Responsible for writing and updating standard operating procedures (SOP) and work instructions (WI) to support the implementation of IVDR.

  • Conduct training on IVDR requirements, new SOP’s and WI’s.

  • Participate in the development and review of performance evaluation plan and report.

  • Review analytical protocols and clinical protocols to assure collection of appropriate data for regulatory submissions.

  • Review labels, labeling, and promotional materials for compliance with IVDR.

  • Provide regulatory opinions on EU IVDR regulatory requirements, export, and labeling requirements.

Minimum Qualifications:​

Education and Experience:

  • Minimum of a Bachelor's Degree in life sciences or engineering.

  • Minimum of 5 years’ experience in regulatory affairs supporting device/diagnostic industry (IVDR/MDR).

  • Minimum of 3 years' experience authoring Tech files and interfacing with Notified Bodies to obtain approval. 

  • 510(k) submission experience is strongly preferred.

  • Demonstrated ability to project manage regulatory submissions.

  • Demonstrated ability to interpret and implement new regulations.

  • Working knowledge of EU in vitro diagnostic or medical device regulatory requirements and quality system standards,

  • Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.

  • Ability to prioritize, multi task, and organize work.

#LI-TECH

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

Apply Now

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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