- 5 active jobs (view)
- Published: May 11, 2022
Description
Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We're looking for an exceptional Senior Regulatory Affairs Engineer to join our amazing team!
Job Description:
As a Senior Regulatory Affairs Engineer, you will:
• Lead processes and projects in regulatory affairs
• Support design and development of products from a regulatory perspective
• Take responsibility on regulatory registration of the company’s products in various countries - especially US and Canada
• Compiling and ongoing maintenance of technical files for registration of the company’s products in the target countries
Requirements
• Education:
o BSc in a scientific area, Bio-medical or Quality Engineering – a must
• Job skills:
o At least 4 years of experience in regulatory affairs in the medical devices industry
o Knowledge and experience of at least 4 years in both of the following regulatory systems: EU / Canada /US
o Submission record for both US (510K) and Canada
• Language skills: English - high level, oral and written
• Other:
o Ability to work under pressure and in tight schedules
o Ability to work in Multidisciplinary work opposite various stakeholders internally and externally
