Job Description

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Quality and Regulatory Affairs Manager

Advertiser: Cylite Pty LtdMore jobs from this company

Job Information

Job Listing Date
6 Jun 2019
Location
Melbourne, Eastern Suburbs
Work Type
Full Time
Classification
Healthcare & Medical, Pharmaceuticals & Medical Devices

 

Quality and Regulatory Affairs Manager

Cylite is an exciting, well funded, start-up company developing innovative optical imaging technologies and medical devices. The company is based in Melbourne, Australia, adjacent to the Monash University Science and Technology Precinct. We are looking for a Quality and Regulatory Affairs Manager with strong medical device experience to build and manage our quality and regulatory team.

About the Role: The Quality and Regulatory Affairs Manager reports has overall responsibility for ensuring that the Cylite QMS and products comply with applicable domestic and international medical device regulatory requirements.  You will work with members of the engineering and production team to ensure that a quality culture is built in to all levels of the business.

Required Skills: Experience with implementation of quality systems in accordance with ISO13485.  Experience with medical device standards and CE, TGA, FDA device approval processes.  Familiarity with IEC 62304 and IEC 60601-1 compliance processes highly desirable. The ideal candidate will have the ability to understand complex medical/scientific technology and communicate with both product engineers and regulators.

Cylite is an Equal Opportunity Employer and embraces diversity and inclusion.

The application form will include these questions:
  • Which of the following statements best describes your right to work in Australia?

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