Basingstoke 01256 336 100

Winchester 01962 865 152

Quality Advisor

  • Location

    Basingstoke, Hampshire, England

  • Salary

    £35k - 40k per year

  • Contract

    Permanent

  • Reference

    JO0000002712

We are working with a large technological and scientific global business in Basingstoke to recruit for a quaity advisor who can manage the regulatory requirements from Competent Authorities in Northern Europe with emphasis on UK/IE

The role is one where you can grow and develop.

You will have a science related degree, have some experience of quality and regulatory bodies and have worked in science or medical related industry with an understandign of a QMS system.

The role involves, but is not limited to:


  • Responsible for Vigilance (adverse events reporting) reporting to the local competent authorities in a timely manner in UK and Ireland/ NEC countries as needed when Corporate notifies of an FSCA or a local reportable incident
  • Responsible for reviewing and coordinating the answers to requests of information from Competent Authorities in a timely manner. Monitoring of all the requests in the company’s vigilance software and other monitoring systems. Escalate on issues as required.
  • Responsible for taking PRE local decisions in case of incidents and to report these in in the company’s vigilance software
  • Communication to customers, third parties and Internal support for other employees regarding regulatory compliance as needed
  • Accountable for reaching the reconciliation of the implemented Field Safety corrective actions in NEC and communicating regularly with the CA
  • Responsible for monitoring the regulatory environment, developing and improving the regulatory processes 
  • Be the Vigilance back-up of the other QMRs in NEC
  • Provide support to the other QMRs in NEC in other QA related topics
  • Travel across NEC and other destinations as and when required


The successful candidate will need:


  • Bachelor of Science Degree in science, Masters’ degree (preferred), experience working with medical devices is desirable.
  • Preferably 3 years of work with Regulatory Affairs, Quality Management, Quality control.
  • Attention to details and ability to understand technical and scientific documentation.
  • Excellent Microsoft office knowledge with documented experience.
  • Good verbal and written communication skills in addition to analytical and organizational skills. 

 

1-1 Recruitment is one of the leading recruitment agencies for jobs in Basingstoke for permanent, temporary and contract recruitment solutions. Due to the high volume of applications we are receiving, if you do not hear from a consultant within 5 days, unfortunately your application has been unsuccessful on this occasion. In the meantime please keep an eye on www.1-1recruitment.co.uk for any other potential vacancies.

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