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Regulatory Affairs Specialist

2 months ago

Eight Mile Plains, Queensland, Australia Cook Medical Full time

About the Role

Cook Medical is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the effective execution of post-market surveillance activities for our medical devices.

Key Responsibilities

  • Plan and lead cross-functional post-market surveillance meetings for our medical device families.
  • Analyze post-market data for inclusion into reports, liaise with stakeholders, and disseminate to our management team.
  • Prepare and submit annual post-market surveillance plans and reports according to regulatory requirements.
  • Provide input and review of periodic FDA reports for PMA and investigational devices.
  • Conduct clinical evaluation in compliance with European and Australian regulatory requirements.
  • Perform tasks in accordance with our ISO 13485 Quality Management System.

Requirements

  • Tertiary qualification in science, engineering, or pharmacy is essential, with a minimum of 3 years of prior relevant experience.
  • Experience within the medical device or pharmaceutical industry is desirable.
  • Exposure to European Medical Device Regulations (EU MDR) is desirable, particularly in areas of regulatory affairs, post-market surveillance, or risk management.
  • Strong MS Excel skills with experience in statistical data visualization and business intelligence software.
  • Experience in medical writing, systematic review, and clinical data appraisal is desirable.
  • Experience managing projects is desirable.

What We Offer

  • Option to work from home 1-3 days a week.
  • Stability of a long-established company.
  • Values recognition and service awards.
  • Base salary plus quarterly paid bonuses.
  • Annual Leave Loading.
  • Subsidised cafeteria & onsite parking.
  • Ongoing support, training, and development.
  • Strong inclusive culture that values our people.

Eligibility

Candidates applying to this role must be a permanent resident or citizen of Australia.