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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

QA/RA Manager/Director


Reference:JCAO0914 Location: Sweden
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Our client a Swedish based start-up medical device company who are developing a novel and potentially ground breaking ophthalmology product are currently seeking a Quality and Regulatory Manager/Director to join their team. Client are developing a natural-based, high quality, cost effective and safe bioengineered corneal implants and Micro lenses to meet the huge demand of the world population suffering from corneal blindness and low vision. The Quality and Regulatory will be responsible for establishing Quality System and getting Regulatory approval for device


Role/Responsibilities

  • Oversee the implementation and ongoing management of an ISO 13485 compliant quality system
  • Lead the team preparing regulatory submissions for EU MDR and FDA
  • Manage the regulatory submission and review process
  • Liaise with regulatory bodies such as notified bodies, competent authorities, and FDA as necessary
  • Lead the team preparing registration of devices internationally (Americas, Africa, Asia, and Pacific Region)

Skills/Experience:
  • University degree in a relevant scientific field
  • Greater than 5 years experience in quality assurance and regulatory affairs working with medical devices controlled by MDD/MDR and FDA.
  • Working knowledge of applicable medical device regulations and standards.
  • Previous experience engaging with regulatory agencies desirable
  • Previous experience with bioengineering desirable
  • Previous experience with medical devices containing animal origin material desirable
  • Experience of working with medical device software would be an advantage.
  • Prior experience and expertise in ophthalmic medical devices, and biomaterials and tissue engineering and the regulatory pathway of ophthalmic medical devices and products (desirable).


For further information please contact James Cassidy [email protected] or call in confidence 086 0204322