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Job Ref.: 1779

Job Title: Quality and Regulatory Manager – Medical Diagnostics – Dublin based – Part-time permanent position – August 2019 - Immediate Vac

Sector: Quality/Regulatory

Location: Ireland, Dublin

Job Type: Permanent part-time

Job description:

Quality and Regulatory Manager – Medical Diagnostics – Dublin based – Part-time permanent position – August 2019 - Immediate Vacancy

Our client is a Dublin based Irish Medical diagnostics company focused on the development of novel panels of cancer biomarkers to aid treatment decisions and allow more tailored patient management, ultimately improving the quality of life for cancer patients.

They are now looking to recruit a Quality and Regulatory Manager to join their team.

The position will be a part-time permanent position.


Management, Direction and Co-ordination of all quality and regulatory activities in the Company


  • Maintain the Company’s Quality Management System
  • Adapt existing Procedures and documents that best meet the requirements of QS and the work-flow within the Company. Create new Standard Operating Procedures, as required
  • Review and approve and have overall responsibility for Risk Management documentation and processes, in conjunction with Product Development Manager, as per company procedures
  • Interact and support Product Development and other staff to facilitate efficient use of resources in compliance activities
  • Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and Regulatory requirements
  • Develop and execute a Quality Audit Plan
  • Ensure adequate and suitable equipment and process validation procedures are in place and being complied with
  • Provide quality oversight of validation (and appropriate re-validation) of equipment, processes and control

  • Coordinate, in conjunction with the Product Development Manager, the overall coordination of each new product’s design and introduction to production
  • Review and approve Design and Development documentation as per OncoMark Design and Development Procedures
  • Provide Quality and Regulatory inputs into Clinical studies
  • Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals
  • Administer the change control, deviation and CAPA systems
  • Update and implement, in conjunction with Product Development Manager, Health and Safety procedures and processes
  • Contribute to Senior Management team in the overall management of the Company


Bachelor’s Degree in an Engineering or Science Discipline


  1. At least 5 years postgraduate experience in Quality environment with at least 2 years at supervisory/ management level, within a Diagnostic/Medical Device Company.
  2. Excellent knowledge of an ISO 9001/2000 or ISO 13485 environment
  1. Experience in the preparation of Technical Documentation

  2. Experience in CAPA system management

  3. An understanding of FDA QSR requirements


  • Organisational and time management

  • Ability to work in a team

  • Problem solving

  • Team leader and motivational skills

  • Listening, writing and oral communication skills

  • Presentation skills


  • Highly self-motivated

  • Ability to work to deadlines and on own initiative

An excellent salary plus benefits package will be offered to the successful candidate.

For further information, please contact Marc Flanagan on Dublin 086 1759252 or email your c/v in the strictest confidence to asap


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