Regulatory Affairs Specialist

Job description

My client is looking for a Regulatory Affairs Specialist to join their ever-growing team.

You will be working with the latest technologies across a broad portfolio of products which includes Programmable Electrical Medical Devices, stand-alone software as medical device, and disposable infusion sets

You will be a regulatory expert and particulate in cross-functional teams.

Job Responsibility

  • Input the develop regulatory strategies.
  • Communicate and compile regulatory requirements to cross-functional groups (MDD/MDR).
  • Prepare gap analysis assessments of regulations to cross-functional groups.
  • Review and approve project documentation.
  • Develops tactics to market commercial opportunities and minimizes time to product launch.

Job Requirements

  • Level 8 (relevant degree).
  • 3 years experience in a similar role.
  • Experience working with regulatory submissions and would have exposure to programmable electrical equipment.
  • Experience in EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series).

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 /

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