BD Nogales Norte · 3 weeks ago
Regulatory Affairs Program Manager
Durham, NC
Full-time
Onsite
Senior Level
5+ years expBD is one of the largest global medical technology companies, and they are seeking a Regulatory Affairs Program Manager to support the Pharmacy Automation business. This role is responsible for managing regulatory activities, assessing regulatory impacts, and ensuring compliance with global regulations.
Consumer Goods
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 Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
BD Nogales Norte 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
Late StageCompany data provided by crunchbase