QA/RA Specialist

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QA/RA Specialist


  Neuchâtel,   100000

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  Quality    Permanent

This is the opportunity to work in an established medical device company in Neuchâtel that develops, manufactures a portfolio of high risk devices in the field of ophthalmology. Whilst integrating within a young and dynamic team you will lead the regulatory function with the opportunity to work across international markets helping to provide patient-focussed solutions.

Responsibilities

  • Be the primary contact for international device registrations and technical files particularly focussing on Europe and Asia.
  • Preparation and follow-up PMCF and support PMS activities according to current regulations (MDD, MDR).
  • Provide support to update and maintain quality management system standards, including: document control, change control, complaint handling, non-conformities/CAPA, vigilance, trainings, risk analysis and validation plan.
  • Provide support for internal and external audits.

Candidate Requirements:

  • Degree or equivalent within scientific or engineering discipline.
  • 3+ years’ experience in regulatory functions in a medical device industry.
  • Good knowledge of MDR and ISO13485 standards.
  • Fluent in English (French desirable).

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

IND123

Hannah.Hughes

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