RA Manager

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.

Job Description:

Managing the post market RA team which handles the following activities:

• Support design and post market compliance of products from a regulatory perspective
• Handling Vigilance, MDR and authorities’ inquiries of complaints
• Support the investigation process from a regulatory perspective
• Responsible for managing product field action
• Responsible on regulatory assessment related QMS process
• Responsible of company’s PSUR
  
  

• Education:
• BSc in a scientific area, (Bio-medical or Quality Engineering - an advantage) or acknowledged regulatory course graduate
• Job skills:
• 3-4 years medical device/pharmaceutical post market experience
• Knowledge and experience with the following regulatory systems: EU / Canada /US - advantage to other regulation
• Minimum 2 years management experience
• Strong verbal and written communication skills
• Good technology expertise is essential
• Experience in front of the authorized authorities
• Understanding of risk management disciplines
• Language skills: English – very high level, verbal and written
• Other:
• Ability to work under pressure and in tight schedules
• Ability to work in Multidisciplinary environment
• Strong interpersonal skills and demonstrated ability to effectively communicate technical content
• Strong attention to detail and accuracy oriented
• Good analytical skills