BD · 16 hours ago
Regulatory Affairs Manager
USA GA - Covington BMD
Full-time
Onsite
Senior Level
5+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Regulatory Affairs Manager will lead regulatory submissions and compliance activities for medical devices, ensuring products meet national and international regulatory requirements for market access and post-market compliance.
Health CareMedical DeviceTechnical Support
Responsibilities
Develop and execute regulatory strategies for new product introductions and product lifecycle management
Prepare, review, and submit regulatory filings (e.g., 510(k), PMA, CE Mark, etc.) to regulatory agencies worldwide
Act as the primary liaison with regulatory agencies during pre-submission meetings, reviews, and inspections
Interpret and apply complex regulatory requirements to product development, manufacturing, and marketing activities
Conduct regulatory assessments for design changes, manufacturing changes, and labeling updates to determine impact and required submissions
Manage and maintain regulatory licenses, registrations, and approvals
Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, Marketing, and Clinical Affairs
Monitor and analyze evolving global regulatory landscapes, assessing potential impacts on products and processes
Participate in internal and external audits to ensure compliance with quality system regulations (e.g., ISO 13485, 21 CFR Part 820)
Develop and deliver regulatory training to internal stakeholders
Qualification
Required
Bachelor's degree in a scientific, engineering, or related field
Minimum of 5-7 years of experience in Regulatory Affairs within the medical device industry
Demonstrated success in preparing and obtaining regulatory approvals (e.g., FDA 510(k), PMA, CE Mark)
In-depth knowledge of global medical device regulations (e.g., FDA regulations, MDD/MDR, Health Canada, TGA, MHLW)
Strong understanding of quality management systems (e.g., ISO 13485, 21 CFR Part 820)
Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information
Strong analytical and problem-solving abilities, with keen attention to detail
Ability to work independently and collaboratively in a fast-paced, dynamic environment
Preferred
advanced degree (Master's or Ph.D.)
RAC (Regulatory Affairs Certification)
Proficiency in Microsoft Office Suite and regulatory submission software
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
2026-01-22
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-20
Medical Device Network
2026-01-17
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