Medical Devices JobsRegulatory Affairs Specialist – Perm – Galway

  • GJ50432
  • Permanent
  • Galway, Galway City

Collins McNicholas

Purpose: Responsible for Regulatory Affairs support of the sustaining activities required to maintain products’ legal status, submissions and regulatory compliance.

 

Key Responsibilities:

  • Working as part of a team responsible for Regulatory Activities with specific responsibility for transcatheter heart valves.
  • Includes preparation and review of technical and process information for global submission activities as well as for change orders, working closely with R&D, DA and Operations groups.
  • Provide support to the core team on all aspects of regulatory strategy for the valve product(s) including development and execution of plans.
  • Review and approve documentation related to product release.
  • Provide input, review and approve facility regulatory activities such as labelling.
  • Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
  • Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
  • Understand and implement the Product Lifecycle processes in particular sustaining activities.
  • Participates in Regulatory Body audits such as FDA, DEKRA, HPRA.

 

 Qualifications:

  • Level 8 HETAC qualification in Science/Engineering discipline or equivalent with minimum 5 years’ experience.
  • Good interpersonal, communication and teamwork skills essential.
  • Previous experience within Regulatory Affairs would be an advantage.

 For additional information please contact Chris O Toole

 

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