DEV-X Consulting

Regulatory Affairs Specialist

Raynham, MA

Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to

  • European Council Directive 92/42/EEC or Regulation 2017/745, as applicable,
  • US FDA 510(k) submissions or Notes to file, as applicable

Bachelor’s (minimum 3 years’ experience) or Master’s (minimum 2 year of experience)
Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of
experience) is preferred.


  • 3 to 5 years of experience in Medical Device industry especially within regulatory, quality or alternatively within engineering 
  • Proven exceptional written and oral communication skills
  • Strong knowledge of
    • ISO 13485 and ISO 9001, QSR
    • Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
    • MEDDEV guidance documents applicable to Medical Devices products and processes
    • FDA requirements
Job Category: Contract
Job Type: Full Time
Job Location: Raynham

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