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Regulatory Certification and Inspection Officer

Job description

Regulatory Certification and Inspection Officer

This person will perform regulatory and general audits, reviewing technical file dossiers submitted by medical device manufacturers. There will be huge exposure to various medical devices and with a huge number of clients. Both permanent and contracting positions available.

Responsibilities:

  • Perform registration, surveillance and recertification for clients, assessing their level of conformance to the related management system. You will also perform audits and prepare any relevant pre and post audit documentations.
  • Conduct internal audits of the QMS.
  • Oversee technical reviews of technical files and documentation for products to assess compliance to certain standards and regulations.
  • Ensure information is shared both ways between clients and internal stakeholders regarding developments in regulatory standards and even technology.
  • Answer any technical queries from clients in relation to audits, regulatory standards or general technical queries.

 

Requirements:

  • Must have two years’ experience in quality management with four years in manufacturing of medical devices or auditing of medical device manufacturing sites.
  • Level 8 degree in medicine, engineering or other relevant science field.
  • Requires strong working knowledge of Medical Device Directives MDD 93/42/EEC; IVD 98/79/EC; AIMD 90/385/EEC, TSE Regulation722/2012; Blood Directive 200/70/EC and ISO 13485:2012. Medical device regulation 2017/745;
  • Preferred orthopaedic experience.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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