Medical Device Compliance Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $130,000
Job Opportunity: Regulatory Affairs Associate

We are seeking a highly skilled Regulatory Affairs Associate to join our team. In this role, you will be responsible for managing end-to-end regulatory submissions, leading regulatory strategy, and compiling technical files.

  • Manage end-to-end regulatory submissions, including interactions with regulatory bodies;
  • 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;
Required Skills and Qualifications

To be successful in this role, you will need:

  • 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 regulatory 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

This is an exciting opportunity to contribute to a high-impact product launch. You will join a lean but dynamic and growing team that values innovation, autonomy, and open communication.

Culture

We have a culture where big-picture thinkers who also dive deep into detail will thrive. Our leadership style is supportive but hands-off, suited to someone emotionally mature and confident in self-managing their workload.

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