Regulatory Affairs Expert

3 days ago

Brisbane, Queensland, Australia beBeeProfessional Full time $80,000 - $100,000

Regulatory Affairs Professional Wanted

We are seeking a highly skilled Regulatory Affairs Specialist to join our dynamic team.

This 12-month fixed term role offers the opportunity to contribute your expertise and experience in regulatory affairs. As a key member of our team, you will be responsible for maintaining design dossiers, technical files and other regulatory documents.

The ideal candidate will possess strong analytical skills, with the ability to meet deadlines, balance multiple priorities and ensure quality standards. They will also have excellent interpersonal skills, including listening, verbal and written communication skills, as well as the ability to work effectively in a team environment.

  • Perform tasks in accordance with our Quality Management System.
  • Maintain regulatory project databases and systems containing approval information.
  • Provide regulatory support on projects as required.
  • Liaise with relevant departments to understand and collate information for regulatory submissions.
  • Prepare device submissions for global markets.
  • Obtain export certificates and legalised documents.
  • Review marketing materials for compliance.
  • Participate in internal quality audits.
  • Ensure culture, values and commitment to Ethics and Compliance by recognizing and enforcing appropriate behavior.

Required Skills:

  • Tertiary qualification in science, engineering, pharmacy or microbiology desirable.
  • Experience in quality assurance or regulatory affairs within a regulated industry desirable.
  • Experience preparing regulatory submissions desirable.
  • Demonstrated ability to meet deadlines and balance priorities.
  • Analytical approach to problem solving with innovative thinking.
  • Highly organized with attention to detail.
  • Flexible and enthusiastic approach to daily tasks.
  • Effective interpersonal skills.
  • Ability to work in a team environment.

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