Compliance Expert

1 week ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $150,000 - $180,000
Regulatory Affairs Specialist

This role presents an opportunity to leverage your expertise in regulatory affairs and contribute to the success of a leading organization. As a Regulatory Affairs Specialist, you will play a pivotal part in maintaining and upholding the company's regulatory profile with Australian authorities.

The primary responsibility is to ensure that products comply with regulations and laws governing their importation, sale, and distribution. This position requires strong relationships with internal stakeholders and applicable regulatory authorities.

A key aspect of this role involves preparing product registration submissions for new products and change notifications for existing products. You will also be responsible for executing the IVDR transition project and maintaining up-to-date knowledge and information on the regulatory environment for medical devices in Australia and New Zealand.

Key Responsibilities:
  • Build and maintain relationships with internal stakeholders and regulatory authorities.
  • Develop and implement RA processes and management systems.
  • Prepare and submit product registration submissions and change notifications.
  • Execute the IVDR transition project.
  • Maintain knowledge of regulatory environments in Australia and New Zealand.
Requirements:

To be successful in this role, you will require:

  • A relevant Bachelor's degree or higher.
  • Significant experience in RA processes and management, preferably in IVD or medical devices.
  • Class IV registration experience would be highly regarded.
  • Excellent communication skills, both verbal and written, and ability to build relationships with key stakeholders.
Benefits:

This role offers:

  • A permanent full-time position.
  • The opportunity to work from anywhere in Australia, with requirement to travel as needed.
  • Flexibility to work with a diverse range of stakeholders.

Please note: This is a unique opportunity for a skilled Regulatory Affairs Specialist to join our team and contribute to our mission.

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