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Regulatory Manager - Medical Devices - Work from home!

Science Solutions Recruitment Ltd
Job LocationManchester
EducationNot Mentioned
Salary40,000 - 42,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

Role: Regulatory Manager - Medical Devices - Work from home!Location: Work from home / Fully remoteSalary: £40,000 - £42,000We are looking to recruit a Regulatory Manager for one of our Household Clients who specialise in Cleaning Products and Medical Devices. This is a fully remote role with all equipment provided for the role. You will have RA experience within Medical Devices/ ISO 13485.Role:

  • Compliance of all Medical Devices placed on the market with relevant national or regional regulations.
  • Acting as the person responsible for Regulatory Compliance in accordance with the Medical Device Regulations EU 2017/745.
  • The Registration of Medical Devices within the territories of sale.
  • The generation and maintenance of Regulatory documentation to support compliance including device technical files. Including but not limited to:
    • Risk Analysis
    • Clinical evaluation
    • Post market surveillance
  • Alignment of regulatory documentation and processes with any requirements of the Quality Management System.
  • Liaison with Notified Body and Competent Authority.
  • Input throughout New Product Development for Medical Devices to ensure compliance when placed on market.
  • Interpretation and communication of Medical Device regulations into actionable plans.
  • Keeping up to date with national/regional regulations for Medical Devices.
  • Covering the duties of the Regulatory Manager for Biocides during limited periods of absence.
Person:Knowledge/Experience/Technical Skills
  • BSc or equivalent in a scientific discipline, medicine, pharmacy, law or engineering relevant to medical devices and at least one year of professional experience in regulatory affairs or quality assurance or, four years of professional experience in regulatoryaffairs or in quality management systems relating to Medical Devices (documented qualification).
  • Proven knowledge, practical implementation and management of all regulations that affect the placing of Medical Devices on the market.
  • Experience of undertaking Clinical evaluation, risk management (ISO14971) and post market surveillance activities.
  • Knowledge of ISO13485.
  • Proven track record of preparation and/or registering Medical Devices in UK/European and/or other international markets.
  • Technical knowledge to be able to liaise effectively with chemists, microbiologists, and virologists.
  • Good communication skills to translate complex regulations and scenarios to different audiences (interview).
  • Working knowledge of regulations for Biocides.

Keyskills :
RegulatoryISO 13485medical devicesRA ManagerAffiars

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