RA Manager

1 week ago

Netanya Center District, Israel Eitan Medical Full time ₪90,000 - ₪120,000 per year

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

Direct manager:
VP of R&A

Requirements:

  • 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

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