Regulatory Compliance Engineer required by a north west based Medical Device company. Permanent position with an attractive salary and benefits package on offer. Excellent role for the right candidate with 2+ years' experience in a medical device or pharma environment.
Please contact email@example.com / 091 373 938 for further information.
Role of this position
- Assist the QA/RA and Env Manager, RA Manager and Quality Compliance manager in the co-ordination, maintenance & integration of the Quality & Environmental Management Systems within the organisation in accordance with the requirements of ISO 13485, ISO 14001 and FDA QSR.
- Responsible for the control and implementation of the Customer and Regulatory Audit schedules.
- 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.
- Responsible for the Corrective and Preventive Activities pertaining to any findings or observations from customer or regulatory audits.
- Participation in the site: CAPA process, Internal Audit process, ECR (Engineering Change Request) process, Training process, Document Control process, Management Review process, Monthly Operations reporting process, Vendor Management process.
- Assist the Regulatory Affairs Manager and/or Quality Compliance Manager with the maintenance of the Quality and Environmental Management Systems.
- Degree qualified or qualification in Quality and/or Technical with a focus on Medical or Pharma sectors.
- 2+ years' experience working in a regulated environment (medical/pharma)
- Must have experience dealing with customers 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 also an advantage.
Please contact Michelle Galvin on (091 373 938) firstname.lastname@example.org for further information on this exciting new opportunity.
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