Bd
Medical Technology
RegulatoryAffairsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“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.
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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