REGULATORY AFFAIRS AND AUDIT MANAGER
- Full Time permanent (40 hours per week)
- Diverse and interesting role
- Salary range $106,735 - $125,570 per annum, depending on experience
- Based in Auckland
About New Zealand Blood Service
Would you like to be part of a dynamic and growing team as a Regulatory Affairs and Audit Manager - a new role in the organisation, whose contribution will save and improve the lives of kiwis and make a real difference, then read on.
New Zealand Blood Service (NZBS) primary objective is to support the New Zealand healthcare community through managing the collection, processing and supply of blood, tissues, cells and organs for transfusion and transplantation. Safety is the cornerstone of everything NZBS does and this is reflected in the quality of the products and services available to the patients in New Zealand. Through this work at the end of every day, you know that you've contributed in some way to making a difference in someone's life.
Our shared values are at the heart of our organisation's culture and guide our behaviour each and every day. They inspire us, motivate us and drive us to provide the very best service to the New Zealand public.
The Quality Directorate is a core team within the organisation, supporting and advising across all functions on quality and compliance issues. We work to Good Practice Guidelines (GMP/GLP) and are licensed by Medsafe and our laboratories to ISO15189 IANZ accreditation. With the appointment of a new Director Quality and Regulatory Affairs and the exciting ambition of the organisation, this team is growing and are now recruiting to the following post.
About the role
This is an exciting opportunity to bring your professional skills to a highly respected organisation and contribute to the fantastic things that we do every day.
You will be joining us at an exciting time, as we grow and build to match the future healthcare needs of the New Zealand population. NZBS has a strong record of continuous improvement, quality and efficiency.
Leading a team of two and reporting to the Director Quality and Regulatory Affairs, the role of Regulatory Affairs and Audit Manager has the responsibility for being the organisation's lead expert in the regulations and standards that apply to our complex organisation.
The Regulatory Affairs and Audit Manager will be the primary interface between NZBS and its regulators on all matters associated with licencing and regulations. This will include negotiations to obtain approval for new and changed activities or products.
You will collaborate with the regulator on the development of strategic initiatives to ensure that NZBS anticipates, has input into, and is prepared for the introduction of any new or changed regulations. You'll also lead the management policy review process to ensure the periodic supply of data to support this.
You will act as the principal point of contact for the interpretation of regulatory requirements and give advice and guidance across all levels of the organisation. You will have responsibility for service development to ensure that new activity is appropriately licenced and new regulations and guidance are implemented in the service.
You will also lead the NZBS audit programmes with responsibility for ensuring that the organisation is aware of, and is meeting its regulatory obligations.
Overall, by analysing and interpreting the regulations, providing expertise to internal stakeholders and managing notifications of new products or changes you will have responsibility for ensuring that the organisation is aware of, and is meeting its regulatory obligations.
If you are looking for an opportunity to challenge yourself and be part of shaping the future of a leading scientific and healthcare organisation, look no further than NZBS.
Key to your success in this role will be your significant experience in Good Practice standards (GMP/GLP/GDP), Medical Device legislation and other mandated accredited schemes. Ideally you will have a background in pharmaceutical or healthcare, with previous experience in a regulated or accredited environment. You will have a tertiary qualification in Science, Regulatory Affairs or Healthcare Leadership or significant experience where you have gained specialist knowledge. You will have previous experience in a leadership role and have a clear understanding of various standards used by NZBS: GMP, PIC/S, ISO15189 etc.
Watch our video on our Recruitment Values!
|Location:||North Island - Auckland - Auckland Central|
|Job type:||Permanent Full time|
|Expertise:||Non-clinical - Quality and Risk - Quality and Risk|
|Attachments:||No File Attached|