Fisher & Paykel - Healthcare
Some industries are in the business to make the world a better place. Fisher & Paykel Healthcare is one of them, with a wide and growing range of highly innovative healthcare products encompassing from infant warmers to respiratory humidifiers to breathing circuits. We are a leading designer, manufacturer and marketer of a range of innovative healthcare devices which incorporate unique features to improve patient care.
At Fisher & Paykel Healthcare, you can expect your career to progress at a rate that reflects your abilities, expertise and ambitions.
Regulatory Affairs Engineer - Auckland, New Zealand
- Title:Regulatory Affairs Engineer - Auckland, New Zealand
- Date listed: Tue 03 Nov
- Apply before: Mon 30 Nov
- Location: Auckland
Ongoing research and development has created a regular flow of new products here at Fisher & Paykel Healthcare. To enable our success to continue we depend on the abilities of our Regulatory Affairs team members to ensure we are able to meet the requirements of international markets.
The role involves being part of our Respiratory Regulatory team ensuring we obtain and maintain market access for our products by meeting international regulations and standards.
You will have tertiary qualified background in either electrical/electronic, mechanical engineering or science. You will have at least 5 yrs experience as a regulatory affairs engineer with medical device experience. Experience in premarket submissions in the US, Europe, Japan and Asia or Latin America is preferred. Your ability to understand, evaluate and communicate technical data is critical.
You will have a strong eye for detail complemented by your methodical, analytical approach. Working with internal procedures and processes and utilising your planning and interpersonal skills will enable you to build strong relationships with our product design, marketing and clinical teams.
Job reference: 14935
The role involves being part of our Respiratory Regulatory team ensuring we obtain and maintain market access for our products by meeting international regulations and standards.
You will have tertiary qualified background in either electrical/electronic, mechanical engineering or science. You will have at least 5 yrs experience as a regulatory affairs engineer with medical device experience. Experience in premarket submissions in the US, Europe, Japan and Asia or Latin America is preferred. Your ability to understand, evaluate and communicate technical data is critical.
You will have a strong eye for detail complemented by your methodical, analytical approach. Working with internal procedures and processes and utilising your planning and interpersonal skills will enable you to build strong relationships with our product design, marketing and clinical teams.
Job reference: 14935
