Senior Medical Device Regulatory Compliance Specialist

7 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $130,000
Regulatory Affairs Specialist Role Summary

We are seeking a skilled regulatory specialist to join our Australia and New Zealand (ANZ) Regulatory Affairs team.

This role offers an exciting opportunity to further develop your regulatory skills across a broad range of therapies and technologies.

Key Responsibilities:
  • Determine and maintain sound regulatory strategies for market entry in ANZ, identifying potential issues early in the planning process.
  • Compile, prepare, review, and submit regulatory dossiers to regulatory authorities, ensuring compliance with regulations.
  • Manage changes to existing products, maintaining continued compliance with regulations and supply continuity.
  • Maintain up-to-date knowledge of regulatory requirements and changes in ANZ, staying informed about industry developments.
  • Liaise with regulatory authorities, negotiating submission details and ensuring timely approvals.
  • Collaborate with cross-functional teams to support product commercialization in ANZ, promoting effective teamwork.
  • Support the review and approval of promotional and advertising materials, ensuring compliance with regulations and industry codes.
  • Maintain accurate and complete regulatory and quality records.
Requirements:
  • Minimum 2 years of experience in regulatory affairs within the medical device industry.
  • Bachelor's degree in science, engineering, or a related field is preferred.
  • Experience with Australian Therapeutic Goods Administration (TGA) regulations is highly desirable.
  • Familiarity with international regulations and requirements is ideal (e.g., FDA, CE Marking).
  • Excellent written and verbal communication skills, with the ability to articulate complex ideas effectively.
  • Strong analytical thinking and problem-solving skills, with attention to detail and prioritization expertise.
  • Understanding of medical device regulations and quality management system standards, with a commitment to compliance.
  • Ability to work collaboratively in a team environment, managing multiple projects and deadlines efficiently.

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