Job Description Summary

Reporting to BD Biosciences (BDB) Sr. Director of Regulatory Affairs, and supporting the clinical platform leader of BDB, the Director of Regulatory Affairs (RA) provides pre-market regulatory leadership to BDB, and serves as a member of the BDB Clinical Platform Leadership Team and BD RA extended LT.

Job Description

We are the makers of possible!  

  

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

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’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

The Director, Product Security – Life Sciences serves as the leader responsible for BD’s product security posture within the Life Sciences Business Units – Integrated Diagnostic Solutions & BD Biosciences. Reporting to the VP, R&D, Product Security, this individual will help the PSO provide guidance to successfully deliver best-in-class secure products, consistent with global regulatory requirements over the lifecycle.

Responsibilities:

Collaborate with all levels and geographies within BD Life Sciences organization, including senior executives, to advance the product security strategy and objectives within the portfolio.

• Ensure adoption of product security framework activities, consistent with applicable global regulations and laws
• Champion strategic initiatives such as leveraging innovative product security processes & technologies or end of support for legacy platforms - in partnership with other cross functional teams
• Engaging BD leadership, customers, federal and international agencies when issues occur as well as speaking in public forums
• Serve as internal security consultant to the organization. Articulate high-level risks and mitigation plans to Senior Management
• Contribute to the strategy and provide guidance on product security matters including architectures, threat models, risk assessments, integration, disaster recovery and maturity assessment
• Oversee delivery of all required product security quality and regulatory documentation associated with product launches in Life Sciences.
• Provide leadership and guidance to BU Product Security Officers in the Life Sciences Segment on critical Product Security issues, tactical alignment, and strategic initiatives
• Provide expertise and management of BU implementation and remediation programs, new product development security solutions, process development, and capability maturity
• Responsible for aligning the Life Sciences Segment around common benchmarks and goals for BD’s enterprise - wide Product Security posture, assessing progress towards these goals while driving improvement
• Accountable for developing BU Product Security Officers leadership skills and influencing BU cross- functional leadership teams to communicate and prepare their organizations for changes in worldwide regulations and standards for Product Security in Medical Devices
• Leadership and development of BU Product Security Officer’s skills in program management, cross functional collaboration, technical and business acumen with their BU leadership teams

Qualifications:

• Minimum of ten (10) years professional business experience, three (3) years leading teams and people, and three (3) years in a Product Security and/or Application Development Security function in a regulated environment
• Experience with connected products, software development lifecycle, security automation, risk mitigation strategies, incident response, and supply chain security are preferred
• Strong understanding of a wide variety of cybersecurity attacks, threats, threat analysis, ethical hacking and system auditing coupled with experience with incident management
• Experience navigating and executing product cybersecurity requirements with 510(k) and PMA- regulated products
• Able to align and connect business strategies with technology solutions that will mitigate risk. Excellent presentation and communication skills including engaging with and presenting to senior leadership team. Strong collaboration skills to include conflict resolution
• Ability to communicate complex technical challenges in a non-technical and simplified manner to business audience

Education:

• Undergraduate degree in cybersecurity, computer science, software en