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SalaryRA Manager, Regulatory Affairs ManagerOpportunity for an experienced Regulatory Affairs Manager to join an Australian owned medical device company. You will play a crucial role in ensuring the company and distribution partners maintain compliance with government legislation and guidelines, locally in Australia and globally.As an RA Manager you will oversee ISO 9001; 2015 process, guaranteeing all standards are met. You'll collaborate closely with the product development team to identify and advise on regulatory requirements for new products, oversee artwork approvals, and collaborate with our international sales team to register products for overseas markets.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.
- Manage QC for all products, in line with our ISO 9001: 2015 and our manufacturers ISO 13485: 2016.
- Developing and overseeing QC testing requirements and standardising testing in line with ISO.
- Management of the companies recall policies and procedures.
- Sc. in scientific or related discipline.
- 5+ years' experience within the medical device industry.
- Knowledge of FDA, TGA, EU medical device regulations.
