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Quality Assurance/Regulatory Affairs Specialist

Quality Assurance/Regulatory Affairs Specialist

  • Location

    Warwickshire, England

  • Sector:

    Supply Chain

  • Job type:

    Contract

  • Salary:

    £100 - £150 per day

  • Contact:

    Elliot Fisher

  • Contact email:

    elliot.fisher@1st-executive.com

  • Job ref:

    J12086_1543998387

  • Published:

    12 days ago

  • Duration:

    3 months

  • Expiry date:

    2019-01-04

  • Startdate:

    ASAP

An excellent world leading Medical Manufacturing organisation are looking to hire an interim Quality Assurance Specialist at £120-150 per day, who are absolute world leaders in their field. They are a rapidly expanding FTSE100 organisation. Initially this will be 3 months, with a view to extend. This is an excellent role for a candidate looking to gain valuable experience within Quality and Regulatory Affairs at a global blue-chip organisation.

Role:

This Quality Assurance position is responsible for representing the function for all Field Safety Corrective Actions.

  • Complete and/or manage Competent Authority reporting activities
  • Act as single point of contact with the UK & Ireland Competent Authorities
  • Collate and report evidence of FSCA closure for each affected country within EUCAN region.
  • Direct non-standard questions to the relevant functions/teams
  • Manage Competent Authority expectations and ensure timeliness of responses
  • Develop and assist in product registrations & re-registrations, including the supply of necessary documents for Europe and Canada and to existing approved countries for our products.
  • Managing and obtaining legalization of documents for our customers.
  • Assist in the development, review and implementing regional policies and procedures based on corporate requirements.
  • Assist in regulatory aspects of commercial business relationships to ensure compliance
  • Assess commercial activities in the EU for compliance and propose and implement potential solutions.

Required Skills:

  • Minimum 1-2 years experiences in regulatory affairs or quality assurance
  • Minimum 3 years Quality Assurance activities related to medical devices.
  • Any dealings wtih MHRA would be preferable
  • Current MDD and new MDR coming into force, however MDD would be preferred.
  • Proficient in Word and Excel, and good writing skill is needed. Experience in MS Access, MS Visio, Agile, and SAP desirable.

If this position is of interest, please apply for the role now. If you have any questions, call Elliot Fisher on 01483 212186.