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

Direct manager: VP of RA and QA

Requirements

·       Education: 

o  BSc in a scientific area, (Bio-medical or Quality Engineering - an advantage) or acknowledged regulatory course graduate

·       Job skills:

o  2-4 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