Head of Regulatory Policy & Intelligence Medical Device

Retained Search

We have been retained on a newly created Head of Regulatory Policy & Intelligence. Reporting to the VP, Global Quality and Regulatory Affairs, the Head of Regulatory Policy will provide strong leadership and strategic direction for Regulatory strategy including the development of a global framework to facilitate and drive Regulatory as a strategic lever. As a member of the Quality and Regulatory Leadership Team, as well partnering closely with the Divisional Regulatory leaders, the Head of Regulatory Policy & Intelligence will be instrumental in facilitating all global regulatory positioning.

Organization: My client is an established and growing Medical Technology company fueled by knowledge, passion, collaboration, and integrity. As a global champion of women’s health, they are focused on improving women’s health and well-being through early detection and treatment.

Job Summary:  The Head of Regulatory Policy & Intelligence is an effective and inspiring influencer with the capability to create followership and to create transparent understanding and guidance to ensure compliance and speed of decisions such that regulatory is a facilitator for growth. Will create confidence and credibility as a trusted partner to business leaders across different functions to build a culture and community of regulatory expertise and optimization of resources and methodology across the enterprise. In conjunction with Government Affairs, identifies and recommends appropriate global regulatory intelligence and advocacy initiatives and for or against regulations through a variety of venues such as participation in external industry organizations, seminar presentations, development of white papers in alignment with business representation and training as well as, where appropriate, engages in the education and guidance to government and regulatory authorities.

Essential Duties and Responsibilities:

• Creates and delivers the strategy and framework to ensure best representation across internal and external forums/networks to achieve strategic goals. Provides impactful strategic advice and recommendations to drive commercial success. Influences internally and externally to ensure effective application and positioning within the regulatory environment to meet business needs.
• Participates in, or oversees participation in, regional committees to drive effective networking and representation to ensure a one voice policy.
• Develops and executes a regulatory intelligence strategy. Keeps abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may impact regulatory strategies and propose action plan.
• Oversees the development and implementation of appropriate systems, processes and standards.
• Establishes metrics to measure success and impact of policy and intelligence activities. Creates a dashboard for senior management on key regulatory and policy issues so that key activities are visible and can be discussed.
• Leads the development of a global regulatory policy and advocacy strategy. Works closely with internal partners and subject matter experts to plan and execute regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. This includes to liaise closely with colleagues (R&D, Policy, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment.
• Drives the collaboration within the company (such as Health Policy teams, Corporate Communications, etc.) to proactively understand and respond to evolving trends and ensures best position for products and access requirements regionally/globally. Creates and implements strategy with internal stakeholders to identify opportunities/threats and advocate company’s positions externally.
• Keeps Regulatory & Quality management and all internal customers, partners, and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensures issues are escalated when needed and encourage resolution at the appropriate level.

Education:         

• B.S./B.A. in a science, engineering, or related technical field is required, Regulatory Affairs Certification a plus

Experience:       

• 10+ years  progressive experience (with master’s degree) and 12+ years (with bachelor’s degree)  with at least: 5+ years working in a Medical Device environment, 5+ years of regulatory experience and 5+ years of experience working with business stakeholders within a cross-functional matrix environment

Skills:

• Advanced knowledge of global regulatory requirements related to medical devices
• Keen ability to analyze, interpret and present complex data and technical documents with ease, and eye for strategic application
• Excellent oral communication skills and demonstrated ability to present, influence and create solid partnerships with executive leaders and regulatory agencies/trade associations
• Proven success in building, development and driving team success
• Inspiring leader that creates energy, enthusiasm and delivery of simultaneous high impact projects and results
• Facilitates development of others and leads to create a followership
• Demonstrated success in navigating through uncertainty, wielding indirect influence over teams
• Drives accountability without authority and creates confidence in regulatory excellence
• Experience in negotiating with regulatory bodies on key issues or submissions

Demonstrated experience in moving regulatory intelligence discovery into action

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