BD · 1 month ago
Regulatory Affairs Program Manager
USA NC - Durham - Roche Drive
Full-time
Onsite
Senior Level
5+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health through innovative solutions. The Regulatory Affairs Program Manager will support regulatory projects in the Pharmacy Automation business, focusing on assessing and communicating regulatory impacts, managing submissions, and ensuring compliance with global regulations.
Health CareMedical DeviceTechnical Support
Responsibilities
Assess and communicate the impact of new and changing regulatory requirements and standards
Develop and execute comprehensive product strategies, roadmaps, and business cases for assigned product lines, aligning with overall business objectives
Review, approve, and document regulatory changes to commercialized devices
Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory changes to partners
Proactively lead regulatory efforts required to align with new regulations and requirements; i.e., EU MDR, MDSAP
Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance
Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards
Work cross-functionally across multiple departments to communicate change impact
Remain current on standards and regulations affecting BD products and communicate and incorporate required changes
Identify ways to improve the efficiency of current work process and implement them
Performs other duties and assignments as required
Qualification
Required
Bachelor's degree
Minimum 5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic and/or regulated product field
Project Management experience
Sound understanding of design control processes, FDA, and global regulations and standards
Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information
Excellent interpersonal, communication and analytical skills
Knowledge of software and instrument design regulations and standards
Preferred
Master's degree in life sciences field (preferred over Bachelor's)
RAC certification (Regulatory Affairs Certification)
PMP certification (Project Management Professional)
Familiarity with Electrical and Electromagnetic Equipment, Machinery, Data and Cybersecurity, Board of Pharmacy, and Environmental requirements
Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle
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
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
Recent News
EIN Presswire
2026-01-09
Company data provided by crunchbase