Senior Regulatory Affairs Expert for Medical Device Launch

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $130,000

Regulatory Affairs Expert for Medical Device Launch

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As a key member of the Regulatory Affairs team, you will be instrumental in ensuring efficient, compliant, and timely pre-market submissions. This is an exciting opportunity to support a high-priority product portfolio during a critical period of growth.

Key Responsibilities:
  • Manage end-to-end regulatory submissions, including interactions with local authorities;
  • Lead regulatory strategy and compile technical files, primarily adapted from EU documentation;
  • Prepare documentation for high-class devices: Class III IVD, Class IIb, and Class III Medical Devices;
  • Review local documentation and assess non-conformance where required;
  • Evaluate the regulatory impact of product and process changes;
  • Review promotional and advertising materials for compliance;
  • Provide regulatory support to cross-functional teams, including commercial and market access;
Requirements:
  • Tertiary qualification in a scientific or healthcare-related discipline;
  • Minimum 3 years of Regulatory Affairs experience in medical devices;
  • Strong technical writing experience, especially with regulatory files;
  • Experience working on local submissions and promotional material reviews;
  • Intelligent, adaptable, and a strong communicator across functions;
  • Self-motivated, proactive, and capable of managing priorities in a fast-paced setting;
Benefits:
  • Work with a global leader in medical technology;
  • Opportunity to contribute to a high-impact product launch;
  • Collaborative environment with flexibility and autonomy;
About the Role:

This is a Senior Regulatory Affairs Associate role that involves supporting a high-priority product portfolio during a critical period of growth. You will play a vital role in regulatory strategy and operations for the ANZ region.

You'll join a lean but dynamic and growing team that values innovation, autonomy, and open communication. This is a culture where big-picture thinkers who also dive deep into detail will thrive.

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