BD Nogales Norte · 2 days ago
Senior Manager, Regulatory Affairs
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a Senior Manager of Regulatory Affairs. This role is responsible for supporting MMS Pharmacy Automation products and overseeing the hiring, training, and development of direct reports while ensuring regulatory compliance.
Consumer Goods
Responsibilities
Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and RoW
Lead regulatory effort to comply with new and existing regulations (e.g., Electrical and Electromagnetic Equipment, Machinery, Data and Cybersecurity, Board of Pharmacy, Environmental)
Lead and develop direct report associates to ensure regulatory compliance
Problem solve and escalate regulatory and compliance issues to senior management as necessary
Provide effective leadership and team development, effective communication, and quick responses to customers
Drive continuous improvement in internal processes and customer satisfaction
Identify, develop, and mentor high performing regulatory talent
Develop and implement global regulatory strategy for MMS Pharmacy Automation products and software
Support the monitoring, interpreting, and implementing of current and new regulatory requirements and international standards for U.S., EU., and RoW
Assure that QMS requirements are followed and executed consistently from RA perspective
Oversee efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
Support regulatory impact assessments for change controls and other RA/QA items from a review and approve level
Assists in preparing, auditing, editing, and publishing registration documentation, as needed
Support business export control (BEC) listing of product for release globally per RA requirements
Performs other duties and assignments as required
Qualification
Required
Minimum of 8 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic and/or regulated product field
Bachelor's degree in biology, engineering, or other science-related discipline
Experience with Regulatory and Quality Information Management systems (SAP, RIM, or related systems)
Digital literacy with MS Word, Excel, PowerPoint, Teams
Project Management experience
Preferred
Advanced degree (e.g., MS, PhD)
RAPS RAC certification
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
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Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase