Pre-Market Regulatory Affairs Senior Engineer

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 Pre-Market Regulatory Affairs Senior Engineer, you will:

·      Lead processes and projects in regulatory affairs

·      Support design and development of products from a regulatory perspective with ability to work with collaboration with cross functional team.

·      Take responsibility on regulatory registration of the company’s products in various countries - especially US, Canada, EU, Israel and Latin America

·      Compiling and ongoing maintenance of technical files for registration of the company’s products in the target countries

·      Ensure compliance with applicable law, regulations and standards.

Direct manager: VP RA

·       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

o  High communication skills

·        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