BD
Senior Director Regulatory Affairs
BD, San Diego, California, United States, 92189
Job Description SummaryThe Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Infusion Process Excellence 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 Infusion 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, the Associate Director of Process Excellence Regulatory Affairs, and execute regulatory strategies and objectives for product development programs and sustaining projects in alignment with business needs, drive timelines for submission/clearance targets, including EUMDR 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 Infusion 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 to 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 global perspective, customer focus, cross-functional collaboration and teamwork skills.
Current and comprehensive knowledge of global regulations and quality systems are required.
Strong project coordination, business acumen and negotiation abilities.
Proven management skills of multi-cultural, multi-national teams, leading and motivating all the Associates towards the shared goals achievement and the individual development.
Travel up to 30%.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
Salary Range Information$199,600.00 - $359,300.00 USD Annual
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This position provides expertise and leadership to business partners, the Associate Director of Process Excellence Regulatory Affairs, and execute regulatory strategies and objectives for product development programs and sustaining projects in alignment with business needs, drive timelines for submission/clearance targets, including EUMDR 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 Infusion 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 to 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 global perspective, customer focus, cross-functional collaboration and teamwork skills.
Current and comprehensive knowledge of global regulations and quality systems are required.
Strong project coordination, business acumen and negotiation abilities.
Proven management skills of multi-cultural, multi-national teams, leading and motivating all the Associates towards the shared goals achievement and the individual development.
Travel up to 30%.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
Salary Range Information$199,600.00 - $359,300.00 USD Annual
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