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RA Specialist

Equashield is a leading medical device company with over 400 employees worldwide that offers a state-of-the-art Closed System Transfer Device (CSTD) for the safe handling of hazardous drugs. The company is committed to protect healthcare workers from the risks associated with exposure to hazardous drugs and vapors. In addition, Equashield is revolutionizing the automatic compounding system with the first CSTD enabled compounding robot that will change the pharmaceutical industry.

Responsibilities:

  • Preparation of regulatory files and dossiers for technical submissions to regulatory authorities according to target markets.
  • Leading regulatory strategy within the automation division  
  • PMS for the division products
  • Responsible for reporting processes
  • Manage product technical files
  • Follow and implement regulatory updates
  • Approval of labelling and supporting documents
  • Participate in design processes and projects

Qualifications:

  • Bachelor degree in the science field or Engineering diploma
  • Proven experience of at least 3 years in Regulatory Affairs of Medical devices or semiconductor devices
  • Knowledge of EU directives 2014/35/EU, 2006/42/EC, EMC 2014/30/EU and 2011/65/EU
  • English proficiency
  • Abilities: Patience, Multitasking
  • Computer skills: Office Applications

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