Eitan Medical
  • 5 active jobs (view)

  • Published: May 11, 2022
Category
Job Type
Level of education
Undergraduate
Spoken Language needed
English
Level of Hebrew
Medium
Location of job
Netanya
How many relevant years experience do you require for the role:
More than 3 years

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

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