Regulatory Manager

Rotherham, England, gb
Company: Real Staffing
Category: Management Occupations
Published on 2021-06-23 06:01:09

Our client is a rapidly growing global medical device manufacturer producing medical technology and smart connected diagnostics. The company operations in the UK, USA and has global commercial networks.

They are looking for a Regulatory Manager to join the team. The successful candidate will be responsible for regulatory activities for manufactured products associated with IVD (In Vitro Diagnostic) medical devices (assays, instruments, software etc.) development through the R&D phase and the verification and validation phase through launch and post marketing arena.

Responsibilities:

  • The Regulatory Manager will be responsible for management of regulatory dossiers of all legal manufactured products for pre and post market
  • Management and Creation of QA/ RA plans for the design and development teams to support Global markets up to the formation of the standard dossier.
  • Creation and maintenance of harmonized standards compliance plans
  • Creation and maintenance of regulatory procedures to align with Global requirements
  • QMS updates required for higher risk IVD's such as PMA and WHO pre-qualification programme activities.
  • Review and approval of change requests for regulatory impact assessment
  • Management of regulatory process relating to marketing collaterals and country localization process
  • Review and approval of Labelling and marketing collaterals
  • The Regulatory Manager will lead and manage a team of Regulatory Specialists working in pre and post market environment, including day to day activities to support the business in accordance with pipeline plans and non-routine activities as required by the business.
  • Support the training and development needs of the team
  • Provide training for other areas of the business on regulatory process and other compliance activities.

    Essential:

    • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/ 79/ EC/ IVDR etc.
    • Development and writing of CE marking technical files
    • Knowledge of Clinical process
    • knowledge of post market regulatory activities including FSCA, incident reporting
    • Experience of working in an IVD or medical device design and manufacturing environment

      Desirable:

      • People Management
      • Experience and knowledge of vertical and horizontal standards for IVD medical device instruments, software and assays in the point of care.

        To find out more about Real please visit www.realstaffing.com

        Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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