About the Company
This company is a market leader in the medical device space and has been operating globally for almost 100 years. With a strong focus on Innovation and Quality, they require an experienced QARA Manager to join the business initially on a 12-month contract and based out of their office in the South Eastern Suburbs.
About the Role
As the QARA Manager you will be critical in the maintenance, development, and continuous improvement of the QMS while being ever present with launch of new products and registrations. In addition, you will further improve current processes and systems relating to regulatory affairs and compliance e.g., ISO13485, TGA, Med safe. Reporting to the Head of Quality & Reg Affairs, you will have two direct reports that you will effectively lead whilst also working cross functionally with all departments to maintain an emphasis on the importance of quality and regulatory standards globally.
Skills and Experience
This is an exciting and integral role within the business for future growth and your experience and skill set will include the following:
- Bachelor's degree qualified in relevant industry.
- In depth knowledge of global regulatory standards
- Ensure the appropriate licensing, marketing, and legal compliance of products, in order to control the safety and efficacy of products.
- Exceptional interpersonal skills with the ability to engage cross functional teams.
- Be responsible for documentation, maintenance and continuously improving Quality System processes required by international, regional, and national regulatory authorities and standards.
This is a chance to showcase your managerial skill set across QA and RA functions. Initially a 12-month contract, there is opportunity to extend.
How to Apply
Click on the APPLY button or contact Tim Barraclough on 0422076399 for a confidential discussion quoting reference number TB20992.