Quality and Regulatory Compliance Manager

  • Established medical honey manufacturer
  • Fantastic lifestyle location – Beautiful Wairarapa
  • Work to global medical device standards 

The Organisation:
ManukaMed is an established and growing company, started with a vision to benefit patients around the world by facilitating the supply of medical grade Manuka honey in the form of well designed, quality products appropriate for medical application. Situated in the picturesque Wairarapa region, ManukaMed sources honey from over 30,000 beehives strategically placed in some of the most remote mono-floral Manuka areas of New Zealand.
The Opportunity:
Reporting to the General Manager, the Quality and Regulatory Compliance Manager oversees all aspects of compliance for ManukaMed’s manufacturing and distribution business ensuring that ManukaMed stay complaint with global regulations for the manufacture and sale of medical devices, Over the Counter products and Food products. This includes, ensuring compliance to FDA, TGA, CE Marking and other applicable regulations.  With a small team of QA Specialists, this role has both strategic leadership and hands-on technical responsibilities.

Applicants must be eligible to work in New Zealand.  This position is based in Masterton.

The Candidate:
Due to the nature of this regulated business and the importance of this role within the company, you will need to have proven experience in managing quality and compliance within the medical device industry, with knowledge of all regulations for manufacture and distribution for regulated products locally and internationally. You’ll have experience in leading, mentoring and supporting your team and also be willing to step in and undertake any responsibilities as required. As an senior member of the operations team, you will support and advise the GM as required.
As the preferred candidate, you will have most or all of the following:

  • Bachelor’s Degree in Engineering, Science, Technology or a related technical field
  • Minimum of 10 years quality assurance/quality engineering knowledge and experience in the pharmaceutical or medical device industry
  • Previous experience in developing, implementing and embedding Quality Systems in GMP regulated manufacturing environments
  • An in-depth understanding of ISO13485 or other relevant medical device regulations
  • Previous experience in medical device, pharmaceutical, or nutraceutical manufacture
  • Strong team leadership experience
  • Training experience and the ability to assess and monitor learning outcomes

Your Application:
If you’ve read this far and would like to know more then please call Tony De Barr on 04 916 0541 or email tony@trs.co.nz .  Or to apply for this position please click on the appropriate APPLY button now.
Note: If this vacancy is not exactly what you are seeking, then please contact me in confidence to discuss your individual requirements.