Regulatory Affairs Officer - IVD

Regulatory Affairs Officer - IVD
  • £35,000 - £50,000 per Annum
    ANNUM
  • Permanent
  • England, UK UK LS23 7FA
Job Ref: J2160981
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 13 July 2021
Immunotherapeautic researcher and developer, boasting increidble growth in the IVD arena. Remote based OR Leeds based

  • NPD within the IVD arena, with an established, growing organisation
  • Benefit from an experienced team, boasting longevity and achievable progression
  • Remote based role, or travel to site in Leeds

SRG partner with an intuitive immunotherapies developer, who operate in the IVD arena as one of their central arms. Due to continual business growth, and in anticipation of further product indications, your expertise as a Regulatory Affairs Specialist if required to ensure their product is successfully registered globally.

RESPONSIBILITIES

  • Support the QA/RA team to ensure that company products comply with relevant IVD regulationsSupporting the regulatory project plan including applicable regulatory submissions
  • Supporting preparation of global pre-marketing and related submissions to support optimal time lines for new/modified product launches
  • Maintenance of product technical files to ensure continuation of compliance
  • Help collect, collate and evaluate scientific data from a range of sources
  • Help to ensure all trials and studies intended to be used for product claims meet regulatory requirements
  • Work within the QA/RA team to ensure consistency of regulatory interpretation, and provide advice to on regulatory requirements as required within the business
  • Guide conformance with applicable IVD regulations in product development and manufacture, support of claims and content of labelling and promotional materials
  • Support creation of labelling specifications and proposed product labelling, advertising and promotional materials after evaluation conformance to IVD regulations
  • Support change control and new product development by providing expertise to ensure that regulatory requirements are achieved
  • Review and evaluate global regulatory impact of proposed product changes. Support preparation of submissions needed to approve such change
  • Support NC/CAPA/ customer complaints process as required including global removal and replacement actions
  • Support post market surveillance activities in accordance with post market surveillance plan. This will include collation of data and report creation at specified intervals
  • Provide regulatory support as needed for any regulatory authority inspections
  • Creation and management of regulatory documentation within the electronic Quality Management system to ensure relevancy and accuracy
  • Ensuring that all work is completed to a high standard within specified time frames and an accurate record of all work is maintained
  • Providing relevant training relating to the regulatory system to all levels of staff within the business as applicable

EXPERIENCE/SKILLS

  • Degree educated, or equivalent in Chemistry/Biological Sciences/Life Sciences
  • Experience working within Regulatory Affairs within the IVD and Medical device industries
  • Demonstrable working knowledge and experience of working within a ISO13485 framework or similar
  • Good understanding of IVD CE Marking requirements
  • Good understanding of global regulatory requirements

For more information, or to discuss your career in the Quality Assurance/Regulatory Affairs arena, please contact Holly Evans on holly.evans@srgtalent.com

SRGTalent
12/08/2021 08:41:35
GBP 35000.00 50000.00 Annum
Contact Consultant:
Holly Evans

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