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.
  
  

• Education:
• BSc in a scientific area, Bio-medical or Quality Engineering – a must
• Job skills:
• At least 4 years of experience in regulatory affairs in the medical devices industry
• Knowledge and experience of at least 4 years in both of the following regulatory systems: EU / Canada /US
• Submission record for both US (510K) and Canada
• High communication skills
• Language skills: English - high level, oral and written
• Other:
• Ability to work under pressure and in tight schedules
• Ability to work in Multidisciplinary work opposite various stakeholders internally and externally