Technical Reviewer - Active Medical Devices

BSI Group

Homebased, China
Fully remote
Medical device technical documentation review
Certification lifecycle management
Regulatory compliance assessment
As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market

Job Summary

  • As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market.
  • BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development and a wide range of flexible benefits that you can tailor to suit your lifestyle.
  • BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate, creating a sense of belonging for all employees while fostering a diverse and inclusive workplace.

Matching Summary

As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market.

Skills & Requirements

Must-have

  • Medical device technical documentation review
  • Certification lifecycle management
  • Regulatory compliance assessment
  • Risk management and design control
  • Client and project management
  • English writing skills

Nice-to-have

  • Mentoring and leadership
  • Ongoing technical training
  • Interpersonal communication skills
  • Flexible working hours
  • Home-based work
  • International environment

Key Requirements

  • Minimum 5 years R&D or design experience
  • Bachelor’s degree in relevant engineering discipline
  • Knowledge of MDD 93/42/EEC, MDR 2017/745, UK MDR 2012
  • Awareness of IEC 60601 Third Edition
  • Familiarity with ISO 14971 risk management
  • Experience with respiratory devices preferred

Work Rights

Not specified

Tailored Resume

Cover Letter