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Regulatory Affairs And Quality Manager

3 months ago

Sydney, New South Wales, Australia I-pharm Consulting Full time

Regulatory Affairs Manager, RA & QA Manager Opportunity:

An exciting opportunity for a skilled Regulatory Affairs and Quality Manager to become part of an Australian medical device company.

You will have a vital role in ensuring that the company and its distribution partners adhere to government regulations both locally in Australia and on a global scale.

  • Collaborate with the product development team to determine and advise on regulatory requirements for new products.
  • Oversee ISO 9001:2015 processes to ensure compliance with all standards.
  • Closely work with the international sales team to register products in overseas markets.

Responsibilities:

  • Prepare and submit documentation to relevant regulatory bodies such as the Therapeutic Goods Administration, FDA, EU, and UK Rep.
  • Offer regulatory support for medical, marketing, and other corporate functions as needed.
  • Manage government approvals for medical devices.
  • Handle regulatory applications for Australia, New Zealand, the US, and UK/European regulatory bodies.
  • Supervise QMS, including document control, to ensure compliance with ISO 9001 and other standards.
  • Manage the company's recall policies and procedures.

Skills Required:

  • Bachelor's degree in a scientific or related discipline.
  • 5+ years of experience in the medical device industry.
  • Proficiency in FDA, TGA, and EU medical device regulations.