Regulatory Affairs Co-ordinator
2 months ago
Our client has built a highly successful product distribution network within ANZ and represents many leading international brands and manufacturers in the home healthcare device industry including several household names.
The Opportunity
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
A team player with a willingness to learn and grow within the role and work closely with external consultants. 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. The Application
To learn more about this exciting opportunity, please email any questions you may have to or call to arrange a confidential discussion with Mark Thomas or Shayalini Wignarajah. To apply, visit our website at and click Apply Now to submit a copy of your current CV and cover letter.
mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries. mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams.
We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.
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