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Senior Regulatory Affairs Specialist - Medical Devices

Posted on Oct 25, 2019 by Michael Bailey Associates - UK Contracts

Solothurn, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Senior Regulatory Affairs Specialist - Medical Devices

We have a new opportunity for a regulatory affairs expert with prior experience in medical devices to support the team in creation and maintenance of Technical Documentation, supporting compliance to European Council Directive 92/42/EEC or Regulation 2017/745 as applicable.

Tasks:

  • Ensure the company's products comply with the regulations set up by government agencies
  • Advise engineering and manufacturing on regulatory requirements
  • Assist with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required
  • Creation, review and maintenance of regulatory related technical documentation
  • Capturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scale
  • Support maintenance of regulatory files and tracking databases

Requirements:

  • Strong experience in Medical Device Industry and Regulatory Affairs.
  • Strong knowledge of ISO 13485 and ISO 9001, QSR
  • Knowledge of MEDDEV guidance documents applicable to Medical Devices products and processes
  • Strong understanding of Risk Management process, label and labelling, change management
  • Understanding requirements of current Council Directive 93/42/EEC
  • Familiarity with Technical Documentation structure according to STED and as required by Medical Device Regulation 2017/745

Technically versed in computer software such as MS Word, Powerpoint.

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 782110325

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