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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:
Job Responsibility:
Managing the post market RA team
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
Requirements:
BSc in a scientific area, (Bio-medical or Quality Engineering - an advantage) or acknowledged regulatory course graduate
2-4 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
English – very high level, verbal and written
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
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