QA and Technical Documentation Officer

Biscuit Factory - London Operations and Business Development

14 Mar 2023

Biscuit Factory - London

Operations and Business Development

Quality Assurance

Full Time


3 years

About you

You are an ambitious and experienced QARA professional with at least 3 years of experience in quality assurance and regulatory affairs in the medical devices industry, particularly medical device design and development. You enjoy learning new things, are solution-focused and happy at the interface of technical, legal and regulatory aspects of product development.

List of primary duties and responsibilities (not exhaustive):

  • Authoring and reviewing medical device technical documentation/DHF/DMR/DHR according to relevant requirements:
    • UK MDR
    • EU MDR (CE Marking)
    • U.S. FDA (Premarket Notifications (510(k))
  • Experience needed in compiling the below technical documentation including:
    • Product specifications
    • Labelling
    • Documentation and verification of design controls
    • Authoring and reviewing development and manufacturing procedures
    • Collating manufacturing records
    • Clinical validation protocols and reports
    • Post-market surveillance and post-market clinical follow-up protocols and reports
    • Compiling and updating risk management documentation (ISO 14971)
  • Liaison between product development, manufacturing, QARA, marketing, HR and legal departments:
    • Coordinate communication as needed to execute QARA tasks
  • Remain up to date on changes to country-specific regulations, updated standards/guidance documents and industry trends.

List of secondary duties and responsibilities (not exhaustive):

  • Maintain and organise the company’s QMS and ISMS including:
  • Compiling new SOPs and policies, updating existing SOPs and policies as needed
  • Management of change control approvals and CAPAs
  • Management of supplier approvals and reviews
  • Preparation and presenting information in management reviews and following up on actions
  • Conducting internal audits, following up on NCs
  • Participate in external regulatory and customer audits
  • Conducting quality and regulatory training as needed
  • May need to carry out quality system administration as needed


  • Bachelor’s degree in quality management, regulatory affairs or related field (medical, scientific or engineering)

Work experience:

  • Minimum of 3 years experience as a quality/regulatory professional in the medical devices industry

Skills (critical):

  • Experience in quality management systems (ISO 13485 / 21 CFR 820)
  • Experience in compiling medical device technical documentation
  • Ability to independently carry out research and summarise findings
  • Strong written and verbal communication skills
  • Extremely high level of attention to detail
  • Flexibility to carry out various tasks within the QA department according to changing priorities

Skills (desirable):

  • Experience in medical device software validation (ISO 62304)
  • Experience in information security (ISO 27001)
  • Experience in UK DPA, EU GDPR and HIPAA regulations
  • An ISO 9001 / ISO 13485 / ISO 27001 internal/supplier/lead auditor certification will be highly advantageous

Job Reference no. QA099