Regulatory Affairs Professional

4 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000
About the Job">

This is a highly specialized role requiring expertise in regulatory affairs within the medical device industry.

The successful candidate will play a key part in developing and executing regulatory strategies to ensure compliance with local and international regulations.

Key responsibilities include managing product registrations, maintaining knowledge of local regulatory guidelines, and collaborating with cross-functional teams to streamline approval processes.

Key Challenges:

  • Define and execute change strategies to drive adoption of new ways of working.
  • Collaborate effectively within the team and with stakeholders to identify needs, set, and execute the regulatory strategy.
  • Maintain up-to-date knowledge of local regulatory guidelines and industry standards, including relevant international standards.
  • Oversee the registration process of medical devices, ensuring adherence to regulatory timelines and expectations.
  • Work closely with product development teams, quality assurance, and manufacturing teams to ensure regulatory requirements are met.
  • Develop and execute regulatory strategies for new and existing products, ensuring clear, comprehensive, and compliant regulatory submissions throughout the device lifecycle.

Requirements

Qualifications:

- Bachelor's degree in a relevant scientific or engineering field.

- At least 3 years of regulatory affairs experience within the medical device industry.

- In-depth knowledge of Australian regulatory requirements, including TGA guidelines.

- Experience with medical device classifications, product registrations, and submission strategies.

- Strong understanding of global regulatory frameworks.

- Excellent communication, organizational, and problem-solving skills.

- A proactive and results-oriented approach to work.

Skills:

- Excellent communication and interpersonal skills.

- Strong analytical and problem-solving skills.

- Ability to work independently and as part of a collaborative team.

About Us

We are a health technology company committed to providing quality healthcare to all. We strive to make a positive impact on society by fostering diversity and inclusion.

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