Our client, a leading Medical Device company in Leitrim, are looking to hire a Regulatory Compliance Engineer.
- 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.
- 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 firstname.lastname@example.org