Medical Devices Regulatory Specialist

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $150,000

**Medical Devices Regulatory Specialist Role**

We are seeking a highly skilled Medical Devices Regulatory Specialist to join our team. The ideal candidate will have experience in regulatory affairs, quality management systems and medical devices.

In this role, you will be responsible for ensuring that our products meet regulatory requirements in key markets including Australia, Europe and the US. You will work closely with project teams to develop and implement regulatory strategies, and analyze local regulatory trends and market intelligence information to make informed decisions.

You will also contribute to the development of our Quality Systems, policies, procedures and specifications. Your excellent communication and interpersonal skills will enable you to build strong relationships with colleagues and external partners.

Our company is committed to delivering high-quality support to our customers. To be successful in this role, you will need to be flexible, proactive and able to adapt to changing priorities.

Key qualifications for this role include:

  • Experience in medical devices/healthcare/pharma
  • Qualification in engineering (preferably biomedical) or similar
  • 2-3 years of professional experience in regulatory affairs or quality management systems relating to medical devices
  • Experience working in an ISO 13485 regulated environment

We offer a dynamic and supportive work environment, with opportunities for career growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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