Senior Regulatory Specialist Position

Vor 4 Tagen


Burgenland, Österreich Life Science Recruitment Vollzeit

Job Summary:

We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our client's team in Galway, Ireland. As a Senior Regulatory Affairs Specialist, you will be responsible for implementing post-market activities, approving Vigilance/MDR reporting, and supporting Regulatory Post Market System improvements.

Key Responsibilities:

  • Develop and implement post-market strategies to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure successful implementation of Field Safety Corrective Action plan and associated activities.
  • Lead Regulatory Post Market System improvements to enhance efficiency and effectiveness.
  • Provide technical expertise to design teams for Key Projects identified by Veryan.
  • Manage and support trend data for regulatory reporting and PMA Annual Periodic Reporting system.

Requirements:

  • A degree-level qualification in Engineering, Science, QA, or related field is essential.
  • A minimum of five years' experience at a senior regulatory level in the medical device industry is essential.
  • A minimum of five years' experience in the creation of regulatory submissions for premarket approval is required.
  • Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.


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