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