Collins McNicholas

Our client, a leading Medical Device company in Leitrim, are looking to hire a Regulatory Compliance Engineer.

Responsibilities:

  • Preparation activities related to both internal and external (customer and regulatory) audits (pre-planning meetings and action tracking).
  • Communication with customers regarding the scheduling of customer audits.
  • Take the lead in customer and /or regulatory audits as required.
  • Responding to any findings related to customer or regulatory audits. 
  • Participation in the site:CAPA process and ECR (Engineering Change Request) process.
  • Assist the Regulatory Affairs Manager and/or Quality Compliance Manager with the maintenance of the Quality and Environmental Management Systems.
  • Deputise for the RA and/or QC managers as required.

Requirements: 

  • Degree qualified or higher in Quality and/or Technical with focus on Medical or Pharma sectors.
  • Minimum of 5 years working in a regulated environment (medical/pharma)
  • Must have experience dealing with customer and regulatory audits relating to ISO 13485 and/or FDA QSR 21 CFR part 820.
  • Must have in-depth knowledge of the ISO and FDA regulations.
  • Knowledge of ISO 14001 Environmental Regulations an advantage.
  • Knowledge of Medical Device Directive 93/42 EEC, new Medical Device Regulation, and related MEDDEVs an advantage.
  • Certified internal auditor (Lead Auditor certified preferred).

For a confidential discussion please contact Mark Whelan on 071 914 2411 or email mark.whelan@collinsmcnicholas.ie

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