Regulatory Affairs Co-ordinator

Posted: 25 May 2022

Medtech     ·     Part time    ·    New role ANZ

Our Client

Our client believes in the power of technology in helping people of all ages take control of their health and wellbeing the smart way. Their broad range of high-quality brands offer devices and accessories that monitor, treat and/or prevent various ailments and help improve your overall quality of life throughout your entire life journey. They are committed to providing great products at highly competitive prices with the best possible purchase and delivery experience.

The Opportunity

Our client is seeking a new part time Regulatory Affairs Co-ordinator to join their team. A new position for this expanding company, your key remit will be to maintain full regulatory compliance for all of their products.  They cover a range of mostly class I and class IIa medical devices- ie. blood pressure monitors, thermometers, nebulisers, pulse oximeters, TENS devices. Also, a range of non-medical devices such as scales, sound machines, water filtration and more.

The Ideal Candidate

  • Developing and maintaining a regulatory affairs checklist and dossier for each product.
  • Liaising with Regulatory Bodies: TGA / Medsafe (WAND) NZ, ACCC / NZCC, AICIS / EPA NZ, ACMA / MBIE NZ, ERAC / EESS.
  • Completion of ARTG submissions/variations/restricted representations with external Regulatory Consultants.
  • Arranging testing for products to ensure meet applicable standards.
  • Liaising with NPD team to ensure regulatory compliance with all new products as part of the development stage, including proofing instruction manuals, packaging, rating labels and advising of updates / over-labelling.
  • Keeping up to date with new, updated and emerging regulations and ensuring product compliance. E.g. UDI framework, software-based products regulations.
  • Ensuring all rework procedures are kept up to date (both internal and external) and notifying relevant internal parties for any in-house rework requirements.
  • Keeping product version number master up to date for all products and checking stock compliance.
  • Enforcement of regulatory advertising guidelines for all products across both digital and print marketing. E.g. Proofing release sheets, catalogues, POS, social media, websites, eDMs etc.
  • Periodic auditing of all products to ensure complete documentation requirements and up to date certificates, DoCs and evidence.

Our Offer

On offer is a salary package designed to recognise your qualifications and experience. Our client is a growing Australian family owned and operated company that has been in the industry for over 80 years. Based in Port Melbourne. If you are interested in joining our client in this exciting new challenge, please call Marilyn Jones on 1300 0 MEXEC for a confidential discussion and/or email your résumé with your cover letter to careers@mexec.com

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