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Quality and Regulatory Affairs Manager

Quality and Regulatory Affairs Manager


A brand new Opportunity for a QA / RA Lead to join a DeepTech / NeuroTech start-up in London. This is a chance to join a rapidly growing multi-disciplinary team pushing non-invasive neurotechnologies to the next level with the aim of improving and saving lives.
This role would suit an experienced quality assurance and regulatory affairs specialist / manager, who has extensive hands-on experience in medical regulations, full medical device development life cycle, and relevant approval processes. You should have a thorough end-to-end understanding of medical QA and RA, and be able to establish regulatory frameworks, perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. You should be able to work effectively and cooperatively with a diverse and multidisciplinary team of engineers and researchers.
Quality and Regulatory Affairs Manager
Salary: £Competitive DOE + Benefits (including stock options, 25 days holiday)
Location: Farringdon (Some WFH flexibility)
Desirable Experience

  • 5+ years of industry hands-on experience working in the medical QA & RA sector.
  • Exceptional understanding of quality system requirements and topics, including trends in the medical device industry and updated compliances post Brexit.
  • In-depth knowledge on medical standards and safety compliance, including ISO13485, IEC60601, IEC80601, and IEC 62304.
  • Risk Management Experience (ISO 14971)
  • Experience in the full product life cycle, V-model product development and system verification/validation process.
  • A good understanding of hardware integration including optics and electronics, and a good understanding of the software verification process.
  • Strong communication skills with the ability to speak effectively to internal and external teams
  • Highly creative first-principal thinker who thrives on hard problems and is a natural person.
  • Experience in planning, coordination and performance of internal and external audits.
  • Good experience on developing and reviewing standardised procedure and reporting mechanisms to generate query, charts and analysis to meet regulatory requirements
  • Good client-facing experience, and provide data analysis in support of internal and external customers as needed, including data related to customer correspondence, surgeon meetings, site visits and regulatory agency correspondence 
  • Excellent documentation and communication skills.
  • Familiar with market entry requirements for different markets, e.g. CE marking process for EU and UL marking (FDA approval) process for US
  • Ability to think strategically and critically evaluate risks to regulatory activities

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