Job Description Summary

Job Description

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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 will be supported to learn, grow, and become your best self. Become a maker of possiblewith us.

The Director of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs. This position is responsible for supporting MMS Infusion products consisting of Medical Devices a along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development, sustaining, and end of life activities. The Director will oversee the hiring, training, and career development of their reports.

• Lead and develop direct report associates to ensure regulatory compliance
• Problem solve and escalate regulatory and compliance issues to senior management as vital
• 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 impactful regulatory talent
• Author and organize regulatory submission content (510(k), Technical Files, etc.)
• Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non-Medical device products and software
• Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• 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
• Support the review and approval of product labeling, promotional, and advertising materials as needed
• Performs other duties and assignments as required

• Bachelor's degree in RA, QA, engineering, or other science related discipline
• Advanced degree (e.g. MS, PhD) preferred
• RAPS RAC certification preferred
• Minimum of 10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field
• Minimum of 7 years of personnel management (direct report) experience including performance evaluations/improvement, and career development
• Software experience including SaMD/SiMD is a plus
• Regulatory and Quality Information Management systems such as SAP, RIM, or related systems
• Digital literacy MS Word, Excel, PowerPoint, Teams
• Project Management experience
• Knowledge of global Regulatory Affairs requirements, regulations and standards
• Experience authoring regulatory submissions (US and Global)
• Strong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projects
• Ability to represent Regulatory Affairs in multiple environments (e.g. Marketing, R&D, and compliance) and work with all levels of personnel, including VP/GM
• Ability to partner with cross-functional colleagues to identify opportunities for regulatory innovation
• Read, analyze, and interpret regulatory literature and documents and effectively communicate information to peers and management
• Ability to work within a team environment and independently with minimum supervision
• Identify and communicate risks and mitigations associated with global regulatory strategies to cross-functional collaborators and act upon these items appropriately as an RA member
• Demonstrated leadership courage through openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed
• Ability to travel globally up to 10% of the time