Senior Director Regulatory Affairs – Dispensing

Senior Director Regulatory Affairs – Dispensing

Requirements

• 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

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

Preferred Qualifications

No preferred qualifications provided.