Description:
Our client is seeking a new part-time Regulatory Affairs Co- ordinator to join their team. Your key remit will be to maintain full regulatory compliance for all our client’s products, working closely with expert consultants in the field. The duties performed within this position will include:
- Developing and maintaining a regulatory affairs checklist and dossier for each product, including periodic auditing.
- Liaising with Regulatory Bodies if required, including TGA/Medsafe, ACCC/NZCC, AICIS/EPA NZ, ACMA/MBIE NZERAC/EESS and others.
- Compiling of documentation for ARTG/WAND entries/variations/restricted representations etc. for submission.
- Arranging testing for products to ensure meet applicable standards as required.
- Liaising with NPD team and manufacturers directly to ensure regulatory compliance with all new products as part of the development stage, including proofing instruction manuals, packaging, rating labels etc. and advising of updates / re-work that is required.
- Keeping up to date with new, updated and emerging regulations and ensuring JAD product compliance.
- Ensuring all rework procedures are kept up to date (both internal and external) and notifying relevant internal parties for any in-house rework requirements.
- Providing advice regarding regulatory advertising guidelines for all JAD products across both digital and print marketing. E.g. proofing release sheets, catalogues, POS, social media, websites, eDMs, blog articles etc.
- Ensuring compliance with Unique Device Identifier (UDI) requirements and updating the Australian UDI Database (AusUDID).
The Ideal Candidate
- Someone looking to enter or re-enter the workforce on a part-time basis.
- Experience with regulatory frameworks and processes pertaining to the sales and distribution of Class I and II medical devices within ANZ. Experience with home healthcare devices (non-medical) is also ideal.
- Strong organisational and problem-solving skills, attention to detail, team player and a keen interest in learning more about regulatory affairs.