My client a leading company in the medical device industry who employs over 48,000 people worldwide currently has an opening for a Regulatory Compliance Engineer to join their team in Carrick-On-Shannon.
This is a permanent role with great benefits.
What will I be doing as a Regulatory Compliance Engineer?
- 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 company's Customer and Regulatory Audit schedules, including:
- 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.
- Assist with the site(s) regulatory requirements related to REACH, RoHS, CLP, etc.
- Deputise for the RA and/or QC managers as required.
What I need to be a Regulatory Compliance Engineer?
- 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 Medical Device Directive 93/42 EEC, new Medical Device Regulation, and related MEDDEVs, preferred.
- Experience preparing 510K pre-market submissions and CE Marking applications, preferred.
- Certified internal auditor (Lead Auditor certified preferred
- Knowledge of ISO 14001 Environmental Regulations an advantage.
Don't miss out on the opportunity to join an exciting company. To apply or for more information please send an up to date CV.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales