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