Job Description Summary

Job Description

M4-14299

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 Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Dispensing and Pharmacy Automation RA organization under the Medication Management Business Unit.  This position is accountable for driving stakeholder engagement, partnering closely with Leadership Teams to further the International Dispensing and Pharmacy Automation Platform innovation agenda, building and maintaining effective relationships with regulators, including applicable Notified Bodies, and key market regulators. 

This position provides expertise and leadership to business partners and executes regulatory strategies and objectives for product development programs and sustaining projects in alignment with business needs, drive timelines for global submission/clearance targets, including compliance, and effectively manage the RA team to ensure functional excellence.

Responsibilities:

• Develops the regulatory strategic roadmap and provides regulatory leadership for programs in the domestic and international space
• Provides strategic guidance to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans
• Actively contribute to key strategic decisions impacting the development of global regulatory compliance policies, processes, and procedures
• Establishes organization goals and objectives and integrates those into the team’s responsibilities
• Creates and defines regulatory pathways for new products; develops regulatory strategies and tactical plans for submissions regulatory bodies
• Liaises with global RA lead(s), to ensure strategic alignment as needed
• Identifies and communicates potential risks and mitigations associated with regulatory strategies to stakeholders
• Directs the preparation of product information for product registrations
• Incorporates Worldwide regulatory developments affecting the Business Group’s Platforms and Programs and communicates emerging opportunities and concerns to stakeholders
• Manages a staff of regulatory professionals responsible for product submission/registration activities
• Assesses resource requirements based on business priorities and allocates personnel as required to meet these objectives
• Develops direct reports required competencies, including, but not limited to, regulatory knowledge and ability to apply and communicate this knowledge
• Conducts training on regulatory issues for staff and for business stakeholders (e.g., Clinical, R&D., Marketing)
• In conjunction with RA business partners, provides input into the budget process for Regulatory Affairs
• Represents the Platform in interactions/negotiations with global regulatory agencies and Notified Bodies; enables / empowers staff to interact and negotiate with regulators
• Represents the Platform in external activities benefiting BD including trade associations, professional organizations, and standards development organizations
• Ensure Regulatory resources are available to support inspections conducted by global regulators

Qualifications:

• M.S. degree in a technical discipline (e.g., engineering, biology, chemistry, regulatory science).  Advanced degree preferred (Ph.D, MBA)
• Experience with Medical devices, pumping systems and/or software driven electromechanical devices required
• Minimum ten (10) years of direct professional experience (Regulatory) in increasingly responsible positions in the medical device field and seven (7) years of management experience
• Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure
• Experience in negotiating with regulatory agencies and Notified Bodies required
• Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions required
• Demonstrated leadership skills
• Demonstrated project management, negotiation, and communication (written and oral) skills
• Demonstrated globa