Regulatory Affairs Specialist
- 16000HBR Requisition #
- Aug 28, 2016 Post Date
Together Medtronic and its Minimally Invasive Therapies Group (formerly Covidien) are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.
Assembly of technical files and regulatory clearance submissions, including US, PMDA, Brazil, Korea, China, etc.
Working with QA, R&D and Operations to obtain appropriate documents.
B.Sc. or M.Sc. in Engineering/ biomedical engineering or Life Sciences
At least 1-3 years of experience with Class II Medical Devices and different regulatory systems
Working knowledge of ISO standards, Submissions: 510k’s, CE, Technical Files, STED