Regulatory Affairs 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

Direct manager: VP of R&A

· 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