Regulatory Affairs Director

Regulatory Affairs Director


Our client a global healthcare company is currently seeking a Technical Device Regulatory Affairs Director to join their team. Director will be responsible for all aspects of Regulatory Affairs for their portfolio of devices


Role/Responsibilities:

• Accountable to define device regulatory requirements and regulatory strategy to development teams to ensure readiness for medical device (MD) and combination product (CP) approvals. Critically review, approve, and lead strategy for global regulatory submissions for device component of all drug / biologic combination products.
• Responsible for company Notified Body (NB) strategy (e.g. selection of NBs for different device technology and/or therapeutic areas) that enables cross-European market launches and post-launch maintenance.
• Drive device regulatory strategies with respect to clinical development, commercial development and CTD submissions. Lead the program team in the development of strategies and plans that ensure compliance to regulations, legislations and standards whilst ensuring appropriate balancing for commercial operation and site compliance needs.
• Function responsible to create and own processes for Technical File dossiers, obtaining NB Opinions, GSPRs and MDD / MDR requirements.
• Directly responsible for liaising with NBs and Competent Authorities to secure CE approvals and NB opinions for all MD and DC for combination products.
• Responsible for the development of technical briefing documents on device development and regulatory plans.
• Accountable for leading and managing a device technical regulatory team to successfully enable development, approval. commercialisation and lifecycle management of deliver MD and DC programs aligned with business plans.
• Responsible to partner with Regulatory Affairs Science Teams to deliver the device component (inc NB Opinions) of combination products for submission.
• Partners with cross-functional teams across the organisation, and in partner organisations, to ensure delivery of regulatory component of integrated project plans.
• Ensure definition, development, maintenance and execution of regulatory plans for MD and DC/CP programs integrated with R&D, Clinical, Regulatory, Commercial and Manufacturing milestones.
• Provide regulatory leadership and planning expertise across the relevant device portfolios, and share such knowledge with peers as appropriate for the advancement of the organisation.
• Ensure the regulatory strategies and content are appropriate to the business need, and actively participate in business go/no go decisions on diligence / BD contracts/acquisitions.
• Identify opportunities for participation in external industry and regulatory consortia to represent and provide positive contribution to current and future challenges within the MD / CP space.
• Maintain a real time view of medical device and combination product submissions, approvals, recalls, 483s etc and use this information to contribute to portfolio level discussion.

• Degree in a pharmaceutical development (science/engineering) discipline, or equivalent
• Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus.
• Experience in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content, OR experience in drug product development, specifically with a focus on clinical interface, regulatory plans and high-level strategy planning.
• Demonstrable track record of competence in leading program teams in problem solving approaches to technical regulatory issues.
• Knowledge of device design controls, ISO, FDA and EU/MDR requirements as applicable to device design, development and regulatory approval.
• Experience of working at a team level where leadership and influencing skills have been applied.
• Well-developed communication skills to lead or facilitate effective technical and project discussions. Is able to communicate regulatory information to key stakeholders.
• Willingness to travel on an as-needs basis. averaging 10% of working year.