Senior Regulatory Affairs Specialist - Medical Devices

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Senior Regulatory Affairs Specialist - Medical DevicesWe 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 agenciesAdvise engineering and manufacturing on regulatory requirementsAssist 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 requiredCreation, review and maintenance of regulatory related technical documentationCapturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scaleSupport 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, QSRKnowledge of MEDDEV guidance documents applicable to Medical Devices products and processesStrong understanding of Risk Management process, label and labelling, change managementUnderstanding requirements of current Council Directive 93/42/EECFamiliarity with Technical Documentation structure according to STED and as required by Medical Device Regulation 2017/745Technically versed in computer software such as MS Word, Powerpoint.

Please send your CVMichael Bailey International is acting as an Employment Business in relation to this vacancy.