Regulatory Affairs Manager

We've got a great role if you love regulatory work in SaMD (software as a medical device) and drug - device combination products. We need a Regulatory Affairs Officer / Manager for this. You will ideally need to be able to get to a King's Cross London office 10 days/ month.

Our client is growing and has a really exciting new range of products for you to work on, supported by their expert team. It's on the cutting edge of new services and support for patients and doctors. The role will be working on global dossiers for regulators, with a focus on the FDA for the USA and MHRA for the UK market but EMEA and experience with other regulators is a huge value.

This position is responsible for carrying out a range of regulatory affairs duties to ensure company combination products are registered in required jurisdictions in a timely fashion and to ensure such licenses are maintained.

Primary Responsibilities:

  • Support the Regulatory Director to ensure that company products being developed comply with regulations.
  • Assist the creation of Regulatory strategies by helping to investigate regulatory requirements / changes in multiple jurisdictions
  • Assist in the creation and update of Regulatory procedures
  • Post market Regulatory activities
  • Help ensure the team is kept up to date with changes to national and international legislation and guidelines.
  • Support the preparation of submission dossiers and scientific advice briefings by helping to develop and write clear arguments and explanations for product licenses and license renewals
  • Support the review of product information for compliance to global requirements
  • Help ensure all trials and studies intended to be used for product claims meet regulatory requirements
  • Provide regulatory support as needed for any regulatory authority inspections
  • Act as primary point of administrative contact for the Regulatory team
  • Perform miscellaneous duties as necessary for the effective completion of the position requirements

Qualifications:

Technical skills and abilities

  • Educated to degree or equivalent level ideally within biological sciences
  • Good understanding of device global regulatory requirements (FDA, EU, UK in particular) essential.
  • Understanding / experience of combination product in these jurisdictions a distinct advantage
  • Understanding of drug product in these jurisdictions and advantage
  • Good experience within a Regulatory role in the Medical Devices industry.
  • Experience of Software as a Medical Device (SaMD) experience with digital apps an advantage
  • Experience of combination products a distinct advantage
  • Experience of clinical aspects an advantage

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Posted
07/15/2022
Location
Central London, England, UK