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Senior Director Regulatory Affairs

2 months ago

lexington, United States LDI Group Full time

Company Overview

Our client is an innovative, specialist diagnostic Medical Device organisation, a global leader in innovative product development and advancement. Present in over 90 global territories they are a key leader in this specialist area - working towards a mission to make the world a healthier place.


Due to an exciting growth trajectory, they are looking for a Senior Director Regulatory Affairs to join the leadership team at this critical time. This person will head up a Global Regulatory function with the objective of ensuring they have a best-in-class regulatory programme and team to facilitate continued development, aligning with worldwide aspirations.


This is a true leadership role that will require the successful person to be on site making critical decisions in real time, driving change, continuous improvements and supporting the regulatory team with training, development, goal setting, succession planning etc.


Core Objectives

  • Build a world class global regulatory strategy & programme
  • Health check, review and build regulatory team to align with global aspirations.
  • Lead the successful planning of workflow for the function
  • Drive and lead the successful submission process for products both Globally
  • Maintain/develop the company’s relationship with the FDA and regulatory bodies
  • Build and develop the company’s regulatory culture/mindset
  • Build and develop the company’s regulatory framework


Candidate Requirements

  • Have established leadership experience in a senior Regulatory Affairs role
  • Have experience with Medical Device, diagnostics, IVD’s, Software products or similar products
  • Must have Submissions experience (Global) – 510K, De Novo, 513 Regs
  • Must have prior history partnering with the business leaders to provide regulatory guidance
  • Must be able to demonstrate experience forming and implementing global regulatory strategies/programmes