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Quality Assurance Manager (Medical Devices)

  • Location

    Basel, Switzerland

  • Sector:

    QA & Test

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Thomas ONeill

  • Email:

    thomas.oneill@darwinrecruitment.com

  • Job ref:

    JN -072020-86613_1593765502

  • Published:

    about 1 year ago

  • Duration:

    12 Months

  • Expiry date:

    2020-08-02

  • Startdate:

    ASAP

  • Consultant:

    #

We are currently searching for a Medical Devices Quality Assurance Manager to be located in Basel on a 12 month contract.

Responsibilities

  • Develop, implement, communicate, and maintain global regulatory strategies and plans for high-tech medical devices
  • Creating, reviewing, and maintaining regulatory related technical documentation
  • Identify and communicate relevant guidance, standards, and regulations
  • Part of the team reviewing product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
  • Working alongside cross-functional teams to obtain relevant information and subsequent review of submission content as needed, assisting with reviews of international product technical documents, marketing, and labelling materials
  • Supporting the maintenance of regulatory files and tracking databases

Requirements

  • Minimum 3 years of experience in European Medical Device industry and regulatory
  • Master's degree in Regulatory Affairs, Engineering or Life Sciences
  • Strong knowledge of ISO 13485, ISO 9001, QSR, Council Directive 93/42/EEC and Regulation 2017/745