Regulatory Compliance Specialist

9 hours ago

Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $140,000

Job Overview:

Regulatory Compliance Specialist

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our Regulatory Affairs function, you will play a critical role in ensuring compliance with global postmarket requirements.

Key Responsibilities:
  • Lead and coordinate regulatory responses to postmarket events (FSCAs, recalls).
  • Draft, review, and report to regulatory health authorities (FDA, TGA, EU Notified Bodies, Health Canada, and others).
  • Ensure accurate and timely documentation of reportable events in partnership with Quality, Clinical, and Product teams.
Requirements:
  • Bachelor's degree in biomedical engineering, life sciences, or a related field.
  • Minimum 6 years of experience in Regulatory Affairs or Quality Assurance in a regulated medical device environment.
  • Demonstrated expertise in postmarket regulatory functions, including vigilance reporting, complaint handling, and FSCAs.
  • Strong technical writing and documentation skills, with attention to regulatory accuracy and detail.
  • Proven ability to work cross-functionally on risk, complaints, or field actions.
What We Offer:
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation package.

This is an exciting opportunity to join a leading organization and contribute to the success of our Regulatory Affairs function. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

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