Regulatory Affairs & Quality Assurance Manager

RA Manager, Regulatory Affairs Manager, RA & QA Manager

Exciting Opportunity for an Experienced RA & QA Manager!

Are you passionate about regulatory affairs and quality assurance in the medical device industry? Our client, a leading Australian company, is seeking a dynamic RA & QA Manager to ensure compliance with government legislation and guidelines both locally and globally. In this role, you will collaborate closely with the product development team to navigate regulatory requirements for new products and packaging. You'll also play a crucial role in registering products for international markets and maintaining meticulous documentation to uphold our client's high standards of quality and compliance.

Responsibilities:

• Identify, prepare and submit documentation to the relevant region regulatory bodies; including but not limited to the Therapeutic Goods Administration, FDA, EU and UK Rep.
• Provide regulatory support for medical, marketing and other corporate functions as required.
• Management government approval for medical devices.
• Maintain regulatory marketing and variation applications for Australia and New Zealand, the US and UK/European bodies.
• Oversee QMS including document control, to ensure compliance with ISO 9001 and other relevant standards.
• Management of the companies recall policies and procedures.

Skills:

• Sc. in scientific or related discipline.
• 5+ year's experience within the medical device industry.
• Knowledge of FDA, TGA, EU medical device regulations.

Apply direct now, or send your updated CV to Ben Byrne at bbyrne@i-pharmconsulting.com OR (02) 8310 5849