Regulatory Affairs

Competitive
Permanent
Galway
08 Oct 2019
BBBH743638

Regulatory Specialist requried for a leading medical device company based in Galway.

Regulatory Affairs Specialist required for a global medical device company based in Galway. This is a permanent role.

Key Responsibilities:

  • Includes preparation and review of technical and processinformation 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
  • 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.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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