Regulatory & Compliance Officer

Location: London

behold.ai is expanding to meet the needs of the global healthcare market with the regulatory and clinical strategy being the core component. To that end, we are looking for a motivated and experienced Regulatory & Compliance Officer to support and progress the implementation of our regulatory strategy.

ROLE RESPONSIBILITIES

  • Lead on the management and maintenance of Medical Device Files for all Behold.ai SaMD products
  • Lead on day-to-day regulatory compliance activities
  • Work closely with Certification Bodies, Notified Bodies, Competent Authorities & Federal Agencies
  • Administer and assist with day-to-day management and administration of our ISO 13485 QMS and our ISO 27001 ISMS
  • Document and support regulatory requirements for UKCA / EU MDR certification (e.g. Technical File, Clinical Evaluation Report, Risk/Hazard Management. PMS etc)
  • Document and support regulatory requirements for US FDA standards (510k & PMA)
  • Administer and assist with the development of internal policies, processes, procedures, work instructions & workflows
  • Work with interested parties throughout the business to support compliance activities relating to:
    • UKCA / Medical Device Directive 93/42/EEC
    • Medical Device Regulation 2017/745
    • FDA Quality System Regulation 21 CFR Part 820
    • Medical Device Single Audit Program (MDSAP)
    • Care Quality Commission Registration Regulations
    • EN ISO 13485:2016
    • ISO 14971:2019
    • IEC 62304:2006 +A1:2015
    • ISO 27001:2013
    • UK Data Protection Act 2018 & EU GDPR
    • NHS Data Security & Protection Toolkit
    • Health Insurance Portability and Accountability Act 1996 (HIPAA)
  • Lead on internal audits
  • Lead on internal regulatory training
  • Lead on medical device Risk/Hazard Management activities
  • Safeguard company information assets, report weaknesses and events in a timely manner
  • Project planning and meeting minute taking where required

ESSENTIAL

  • Advanced level experience in the Medical Devices industry
  • Advanced level experience of Quality Assurance and ISO 13485 QMS Administration
  • Advanced level experience with Medical Device CE Marking including the creation and maintenance of Technical Files and associated documents/records
  • Intermediate level experience with Medical Device FDA submissions (e.g. 510k submission) and associated documents/records
  • Intermediate to advanced level experience of working with Software Medical Devices
  • Intermediate level experience of supporting software engineers to achieve compliance with the requirements of the IEC 62304 standard
  • Intermediate knowledge and experience of Post Market Surveillance requirements for the UK, EU and US including contribution to Post Market Surveillance Reports and/or Periodic Safety Update Reports
  • Intermediate level experience in internal Audit
  • Knowledge of the GDPR, HIPAA and other global data protection regulations

NICE TO HAVE

  • Previous experience of working with NHS organisations
  • Previous experience of project management
  • Information Security and ISO 27001 ISMS Administration experience
  • Experience in establishing/improving Software Development Lifecycle Processes
  • Project management experience

PERSONAL QUALITIES

  • Hardworking result-oriented person
  • Diligent and conscientious
  • Keen to work in a small target-focussed team
  • Ability to perform effectively in complex environments
  • Ability to think of the bigger picture whilst able to focus on details where required
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