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Regulatory Affairs Specialist - Remote (East Coast)

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-359476 Date posted 02/11/2020

Job Description Summary

Job Description

Regulatory Affairs Specialist –Microbiology:  Reports directly to the Associate Director of Regulatory Affairs Microbiology, Integrated Diagnostic Systems.

This position provides regulatory guidance, develops regulatory strategies and risk assessments to product development/support teams to market new or modified medical device and in vitro diagnostic products.  This position prepares US FDA Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, and 510(k) submissions in addition to Technical Files and Dossiers in support of CE Marking in compliance with EU Regulations. 

*Ability to work remote on the East Coast*

RESPONSIBILITIES:

  • Understands and interprets U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements.
  • Provides guidance on regulatory requirements to product development teams.
  • Develops strategies for submissions to FDA and other regulatory agencies.
  • Provides risk assessments and compliant regulatory options.
  • Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements.
  • Prepares Technical Files and/or Dossiers for CE marking, to include obtaining documentation and support from Quality and other functions to maintain compliance, and interfaces as needed with Notified Bodies regarding significant changes to products. 
  • Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S.
  • Interacts and negotiates with U.S. regulatory agencies under the guidance of regulatory leadership.
  • Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.
  • Participates in the development and review of product release documents.
  • Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.
  • Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.
  • Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirements

EDUCATION:

B.S. degree or higher required, strongly preferred in a technical discipline (biology, microbiology, molecular biology, bioengineering).

RAPS RAC (U.S.) preferred.

EXPERIENCE:

  • Minimum 3 years of experience in the medical device and/or in vitro diagnostic device area is required, preferably in the area of regulatory affairs.
  • Experience in identifying and interpreting relevant medical device and in vitro diagnostic regulations and guidances.

SPECIAL SKILLS:

  • Ability to effectively communicate both verbally and in writing to all levels within the organization and externally.
  • Ability to handle multiple tasks, organize and prioritize work, maintain schedules, and provide updates to managers and cross-functional stakeholders.
  • Ability to think strategically, identify complex or ambiguous issues, propose solutions and escalate to team members and supervisors.

KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:

  • FDA regulations and policies applying to medical devices and in vitro diagnostic devices including, but not limited to, requirements for 510(k)s, IDEs, PMAs, labeling and promotional materials, and Research Use Only devices. 
  • EU regulations including, but not limited to, MDD 93/42/EEC and IVDD 98/79/EC. 
  • Working knowledge of 21 CFR 820 - Quality System Regulation, ISO:13485, ISO: 9001, Good Clinical Practice, and Good Laboratory Practice.
  • Working knowledge of regulatory and quality standards applicable to business unit products.

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.

#LI-TECH

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift

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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.

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