Pharmaceuticals & Medical Devices (Healthcare & Medical) Full time Magic Mobility designs and manufactures all terrain powered wheelchairs. Our wheelchairs are sold in a Global Marketplace and give people freedom and choices in their lives to push boundaries with "go-anywhere" technology.
As the Quality and Regulatory Manager, you are responsible for ensuring that Magic Mobility products meet the requirements and expectations for both our customers and our internal stakeholders. Your role serves as the PRRC (Person Responsible for Regulatory Compliance) for Magic Mobility.
Through the Quality Management system, you ensure that the product testing, manufacturing systems, production documentation, and other related tools/processes are in place to ensure regulatory compliance and product quality and reliability.
You manage the Quality operations of the Magic Mobility manufacturing site with Key Metrics and Quality management principles.
You are responsible for regulatory compliance and should possess the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management system relating to medical devices;four years of professional experience in regulatory affairs or in quality management system relating to medical devices.Magic Mobility is part of the Sunrise Medical Group, as such you shall work closely with the Sunrise Medical global Quality & Regulatory teams ensuring global compliance to medical device regulations.
The QARA role reports into the Global Regulatory Director of Sunrise Medical, and the General Manager of Magic Mobility.
Only applications with cover letters that have been written for the role will be considered.
Your application will include the following questions:
Which of the following statements best describes your right to work in Australia?How many years' experience do you have as a Regulatory Affairs Manager?How many years of people management experience do you have?What's your expected annual base salary?How much notice are you required to give your current employer?How many years' experience do you have as a Medical Device Manager?How many years' experience do you have as a Regulatory Associate?How many years' experience do you have as a Head of Quality? #J-18808-Ljbffr