Quality Assurance & Regulatory Manager

Weybridge  ‐ Onsite
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Description

Key Responsibilities:
  • Maintain ISO 13485 certification
  • Maintain the Marketing Authorisations for the U.K., Ireland, Portugal, Netherlands, Norway and other markets.
  • Maintain the U.K. Wholesale Dealer Licence
  • Ensure Adverse Events, Product Quality Complaints and Safety Requests (Pharmaceutical and Medical Device Products) are escalated and closed as per corporate procedures
  • Degree Level education, science, maths or engineering preferred
  • At least 3 - 5 years Regulatory experience in the medical device and/ or pharmaceutical field
  • Experience of maintaining an effective Quality Management System
    (ISO 13485) required
  • Demonstrated ability to Interpret and simplify medical device and pharmaceutical legislation, and implement effectively in an operational team
  • Demonstrated ability to maintain customer focus whilst delivering on mandatory legislative requirements
  • Ability to analyse data and produce summary of results
  • Solutions orientated with experience of working in a commercial sales environment


Quality Management Systems (QMS)
  • Ensure continued certification to ISO 13485 across the facilities
  • Develop and implement an effective QMS that enhances the customer facing value of the organisation and reduces business risk
  • Key activities include ownership of management review, internal audit, CAPA and document control


Pharmacovigilance (PV)
  • Marketing Authorisation Holder (MAH) and Responsible Person (RP) for defined European countries
  • Ensure the collection of Adverse Event (AE) reports and Product Quality Complaints (PQC) within 2 days of receipt and follow up as per the company SOPs or at the request of the European Qualified Person for


Pharmacovigilance (EU QPPV)
  • Review and reconcile medical information enquiries on a monthly basis to confirm that all AEs and PQCs have been identified and logged
  • Archive of all source documents for AEs and PQCs in an appropriate secure manner.
  • All source documents will be held indefinitely and not destroyed without the permission of the EU QPPV
  • Liaison with the DENTSPLY Pharmaceutical Business Unit and the National
  • Regulatory Authorities for the submission of all case reports, periodic summary update reports and safety requests
  • Coordinate National Regulatory Authority PV inspections with support from the EU QPPV and Pharma Business Unit.
  • Provide information on all local commercial agreements which may impact on PV to the Pharma Business Unit and any other data requested for inclusion in the Pharmacovigilance system Master File.
  • Relevant contracts should include appropriate safety process clauses
  • Notify the Pharma Business Unit and EU QPPV of any changes to local PV legislation of which they become aware
  • Ensure that all relevant staff with the local company have received
    pharmacovigilance training appropriate to their role


Experience Required
  • Degree Level education, science, maths or engineering preferred
  • At least 3 - 5 years Regulatory experience in the medical device and/ or pharmaceutical field
  • Experience of maintaining an effective Quality Management System (ISO 13485) required
  • Demonstrated ability to Interpret and simplify medical device and
    pharmaceutical legislation, and implement effectively in an operational team
  • Demonstrated ability to maintain customer focus whilst delivering on mandatory legislative requirements
  • Ability to analyse data and produce summary of results
  • Solutions orientated with experience of working in a commercial sales environment


For more information on this role this role please send across your up to date CV or get in touch with Oliver Davies on . For more information on this role please follow the hyperlink: https://uk.linkedin.com/in/medicaldevicesqara
Start date
04/2016
Duration
Permanent
From
Real Staffing
Published at
12.04.2016
Project ID:
1108520
Contract type
Permanent
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