Regulatory Affairs Manager Medical Devices, Quality Oversight



Reporting to the Managing Director, you will be part of the local leadership team. This position is responsible for leading a small quality team and supporting regulatory applications in ANZ and globally. You will be responsible for a niche range of medical devices Class 1 that are distributed in over 120 countries.

The key responsibilities of this position include: Previous experience in a GMP manufacturing environment for medical devices; Strong understanding of TGA and FDA regulations for medical devices; Skilled in managing QMS as per ISO 9001 and ISO 13485 standards; Strong ability to influence and build excellent relationships with internal and external stakeholders; Prior experience managing a team as this individual will be managing a QA Officer and a QA Engineer; Flexibility to travel to Melbourne on a fortnight /weekly basis and oversee a robust QMS system. The key attributes required for the role are: Relevant tertiary qualifications in Science & Engineering 8 years' experience in a regulatory affairs & quality related role Leadership and business partnering skills Strong knowledge of regulatory framework for medical devices in ANZ Strong communication and team building skills Knowledge of Quality Management Systems is desirable An individual who is down to earth, collaborative, quality and customer focused A professional who can work in an environment with a practical family feel, who are experiencing year on year growth. This Sydney based position offers an attractive salary package, For more information, please contact On Q Regulatory Affairs Team on 02 9431 2555 Please send your Cover Letter and Resume in Word Doc Format (no text boxes or tables please) and follow the Apply Links.

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20 Sep 2019


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