Bd

Medical Technology

RegulatoryAffairsSpecialist

$84–139k Franklin Lakes, New Jersey, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Regulatory Affairs Specialist at Bd. Skills: Regulatory affairs, Medical device regulations, Regulatory filings. Prepare and submit regulatory filings. Review product changes for regulatory impact”

Industry & Context.

Medical Technology
Problems you'll solve

Analytical; Problem-solving; Decision-making

What They're Looking For.

Must Have

Bachelor's degree in scientific discipline, 1+ years medical device industry experience, Understanding of global medical device regulations, Experience preparing regulatory filings, Analytical skills, Problem-solving skills, Decision-making skills, Proficiency in Microsoft Office Suite

Nice to Have

RAC certification is a plus

What You'll Do.

Prepare and submit regulatory filings

Review product changes for regulatory impact

Update existing regulatory submissions

Support regulatory strategy development

Integrate regulatory requirements

Participate in audits and inspections

Provide regulatory expertise

Provide documentation for audits

Monitor global regulations

Interpret regulations and standards

Maintain regulatory documentation

Maintain regulatory databases

Assist in responding to inquiries

Assist in responding to requests

Provide regulatory support for post-market surveillance

Support adverse event reporting

Support recall activities

How You'll Work.

Team & Collaboration

Cross-functional teams; R&D; Quality; Marketing; Clinical

Communication Scope

Written communication; Verbal communication

Full Job Description

## **We are the people who give possibilities purpose** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. # Job Description We are**the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker of possible** with us. The Regulatory Affairs Specialist at Becton, Dickinson and Company is responsible for supporting the preparation and submission of regulatory documents to health authorities, ensuring compliance with global regulations for medical devices. **Job Responsibilities:** * Prepare and submit regulatory filings (e.g., 510(k)s, Technical Files, Design Dossiers, PMAs) to global health authorities in accordance with applicable regulations and company procedures. * Review and assess proposed product changes for regulatory impact and ensure timely updates to existing regulatory submissions. * Support the development and maintenance of regulatory strategies for new product development and existing product lines. * Collaborate with cross-functional teams (e.g., R&D, Quality, Marketing, Clinical) to ensure regulatory requirements are integrated t

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