Job ID R-478146 Date posted October 23, 2023

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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Job Description Summary

Job Description

Our vision for Regulatory Affairs at BD

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric attitude.

About the role

As Regulatory Affairs Director you will define, develop and lead global strategies to improve global regulatory success towards achievement of program objectives for complex projects. In this role you will ensure global regulatory plans accommodate appropriately achievement of business objectives and optimally communicates with project teams, line management and key partners on any developments that may impact regulatory success.

Main responsibilities will include:

  • Provide innovative ways, strategic and tactical mentorship to resolve regulatory issues and increase speed to market
  • Ensure high quality collaboration with Regional Regulatory partners by providing timely guidance and partnership in health authority meetings and regulatory documentation spanning throughout the product lifecycle
  • Provides guidance on planning, writing and review of dossier documents for submissions globally
  • Represent BD in interactions with health authorities for the product portfolio assigned
  • Lead cross-functional stakeholder alignment to drive robust regulatory submissions
  • Remains on the forefront of the relevant science and competitive landscape via actively contribution to policy shaping efforts including partnering with trade associations; viewed as an expert in its application to the regulatory process
  • Coach and mentor team, create an open, inclusive environment for associates to grow and challenge themselves

About you

We are looking for experienced leader in Medical Device Regulatory Affairs with expertise in global regulatory requirements and standards applicable to medical devices (software-hardware integrated technologies, apps, cloud solutions, digital tools) e.g., ISO13485, QSR, EU MDR, US FDA – 510k and PMA.

Your attributes include:

  • Knowledge of and experience in pre-market regulations including regulatory and risk management processes
  • Experience in all regulatory compliance aspects of the business: pre-market, commercial, and post-market
  • Excellent verbal and written communications skills.
  • Strong project coordination, business acumen and negotiation abilities
  • Ability to lead, develop and empower multi-cultural and multi-national teams

Click on apply if this sounds like you!

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.

To learn more about BD visit:

Primary Work Location

CHE Eysins - Business Park Terre-Bonne

Additional Locations

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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

Advancing the world of health™

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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.

Brian Carney
Staff Regulatory Affairs 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.

Robin Cassell
Global Regulatory Operations Labeling Specialist

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.

Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist



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