Associate Director Regulatory Affairs - Medical Devices & Companion Diagnostics

  • Salary: On application
  • REF Number: 00050106
  • Consultant: Julia Day
  • Contact: 07963 409838
  • Date Published: 31.03.2021
  • Sector: Genetics & Biologics, Medical Devices
  • Location: Ireland, Ireland (Cork area), Ireland (Dublin area)
  • Discipline: Regulatory Affairs

CK Clinical is recruiting for an Associate Director, Regulatory Affairs to join Boyd Consultants. The role will specialise within medical devices and companion diagnostics and will be part-time (3 days per week). This role is based in Ireland. Boydsare a consultancy providing a wide range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Working with early stage biotechs, medical device companies and universities, theteam supports the development of advanced therapy medicinal products (ATMPs), small molecules and biologics across a wide range of therapeutic areas.

Responsibilities: As Associate Director, Regulatory Affairs you will independently lead projects to develop, review and execute regulatory strategy for clients, and will also take the lead delivering regulatory activities/submissions necessary to support product development and registration.

Key duties will include:

  • Providing expert strategic advice to clients for companion diagnostics and novel devices.
  • Providing global regulatory diagnostics strategic advice to clients including EU and US.
  • Preparing and submitting high-quality regulatory documents including but not limitedto, CE documentation, US Q-submissions, US premarket approvals (PMAs) and notifications (post approval reports, annual reports, establishment registration and device listings).
  • Lead regulatory agency interaction and negotiations.
  • Be a leader in developing new procedures/processes for complex ATMPs.

Qualifications:

  • Significant experience in medical device regulatory affairs with experience in Companion Diagnostics and ATMPs preferred
  • Experience leading the development of Regulatory Strategy.
  • Self-starter with the ability to independently find creative solutions for complex problems. A strong customer focus with a flexible approach to work and a willingness to share ideas and experiences

Apply: For more information please contact Julia Day or email boyds@ckclinical.co.uk. Please quote reference 50106 in all correspondence.

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