Job Summary

The Regulatory Affairs Associate is required to work on a wide variety of regulatory tasks in maintenance of technical documentation, CE marking new devices and maintaining technical files to meet Australian, Canadian and US FDA requirements.  These include routine updates in relation to change control, introduction of new devices, support activities in CE marking new devices and file remediation to meet global regulatory requirements. 

Essential Duties and Responsibilities

• Writing and updating technical files to meet applicable regulatory requirements, to included Essential Requirements, General Safety and Performance Requirements, Device classification, compiling technical documentation, identification of standards (& gap analysis), updating declarations of conformity etc. 
• Undertaking product registrations overseas, maintaining a database of all overseas registration certificates, following up with distributors on expiry. 
• Providing data and reports to other departments as required to fulfil customer requirements, redacting data as necessary.  Reviewing and amending distribution agreements as required. 
• Reviewing and approving document change orders on behalf of Regulatory Affairs.
• Implementation of routine technical file changes and updates on a regular basis, ensuring that the technical files are always up to date. 
• Undertaking standards reviews, and gap analyses
• Compiling protocols and reports for PMS. 
• Reviewing and advising on labelling requirements, writing instructions for use. 
• Maintaining standards of quality set by the company as regards attention to detail and accuracy of all work undertaken.
• Perform other duties as assigned by manager or supervisor.

Experience & Education Requirements

• Bachelor’s Degree in suitable scientific discipline.
• Minimum of 2 years’ experience of writing/updating medical device technical documentation required
• Strong working knowledge of US FDA requirements and guidance’s, Australian Therapeutic Goods Act and Health Canada Food and Drugs Act. Experience of 510ks preferred but not essential. 
• Good working knowledge of EU regulations MDD and MDR.         
• Strong working knowledge of common Medical Devices standards including but not limited to ISO13485, 14971, 15223-1, 10993 series, ISO 20417.
• Good IT literacy is required – specifically Microsoft Word and Excel