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Job Description

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 mgalvin@careerwise.ie / 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.

JOB REQUIREMENTS

  • 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) mgalvin@careerwise.ie for further information on this exciting new opportunity.
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Manufacturing & Production

Engineering & Technical

Scientific & Laboratory

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CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie