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Senior Regulatory Affairs Specialist

Quality & Laboratory
Cork
Danielle Francois
Permanent
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Job Reference: JO-2103-65694_1617015679

Summary:

If you are a regulatory professional and have the drive to work with an organisation that has a stellar and long-held reputation this role could be of immense interest to you.

This organisation has a built a reputation of innovation in Research and Development and commercially in the world of eye car. With two buyout categories of business, Visioncare and Surgical, the team has been delivering patient-focused solutions for decades.

This role, Senior Regulatory Affairs Specialist is the cornerstone of regulatory affairs in the organisation's Cork-based facility and will lead regulatory and continuous improvement projects.

On a typical day, you could be working on

  • New Product introductions
  • Supporting LCM Project ensuring consistent compliance with market regulations
  • Participating in internal and external regulatory/quality audits
  • Preparing Regulatory Submission Dossiers for submission to global regulatory agencies and organisations

Required

  • Degree in Science or Engineering or equivalent
  • 7 + years in a regulated medical device environment (ISO 13485)
  • Excellent communication skills, with a keen eye for detail
  • Well-developed organisational skills, deadline focused
  • The desire and drive to thrive in a fast-paced environment

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Danielle Francois
Danielle Francois
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