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Quality and Regulatory Manager

Job in Dublin - Ireland
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Company: Scientificjobs
Full Time position
Listed on 2020-01-07
Job specializations:
  • Management
    Operations Manager
  • Pharmaceutical
    Pharmaceutical QA
Job Description & How to Apply Below

JOB TITLE: Quality and Regulatory Manager


REPORTING TO: CEO


CONTRACT TYPE : Permanent, part-time.


MAIN ROLE:

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


RESPONSIBILITIES:

  • 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 the 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 ofvalidation (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 the companies 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



  • PRINCIPAL QUALIFICATION REQUIRED:

    Bachelor’s Degree in an Engineering or Science Discipline


    WORK EXPERIENCE:



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


  • KEY SKILLS:




  • 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


  • PERSONAL ATTRIBUTES:




  • Highly self-motivated
  • Ability to work to deadlines and on own initiative


  • Position Requirements
    Less than 1 Year work experience
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