Summary A Senior RA 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.
Job Purpose Working in the RA department to ensure that the devices meet worldwide regulatory requirements Ensuring all applicable regulatory requirements are met, including EU, USFDA, Health Canada and Australia.
Write and update Technical & Master File Documentation to meet new requirements as laid out by EU MDD/MDR, US FDA, Health Canada and TGA.
Key Responsibilities and Authorities
- 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.
- Reviewing contracts and dealing with suppliers in sourcing documentation as required.
- Maintaining standards of quality set by the company as regards attention to detail and accuracy of all work undertaken.
Education: Degree qualified in a suitable scientific discipline.
Experience: A Minimum of 7 years’ experience of writing/updating Medical Devices technical documentation is 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.
Experience of MDSAP for US/Health Canada, Australia preferred but not essential.
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
Key Skills and special aptitudes:
The following skills are also essential:
- Working knowledge of Medical Device quality systems
- Understating of ISO 13485, FDA QSR 820, ISO 14971
- Working knowledge of EU MDD/MDR
- Minimum 7 years’ experience in regulatory affairs (medical devices, not IVD)
- Excellent communication skills
- Ability to work independently to tight deadlines and flexibly across multiple tasks.
- Strong oral and written communications skills
- Ability to assimilate information, summarise and present in the format required.
- Attention to detail and accuracy.
- Good organisational ability and time management
- Good literacy and numeracy.
Disposition and personal qualities:
- Must have excellent analytical skills and good attention to detail
- Task-oriented. A strong completer-finisher.
- Ability to multi-task
- Cheerful disposition
- Positive attitude towards work
- Strong team player
- Reliable, punctual with a high degree of integrity
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