הנדסה ו-R&D

QA/RA Manager

100771

תאריך עדכון

05/08/2018

תיאור המשרה

1. Knowledge/Educational requirements:
B.Sc degree or higher in a technical discipline, preferably in biology, chemistry / equivalent
Degree in industrial engineering /QA – an advantage

2. Experience:
3 year experience managing and implementing QMS and regulatory preparations and submissions.
Experience in ISO13485, CE and FDA – a must.

3. Skills and abilities:
Positive Approach, Excellent Interpersonal Relations, Highly Motivated, Possess High Personal drive and accountability.
Motivated by small company environment
Word, Excel, PowerPoint, ability to create documents and presentations in collaboration with R&D Team
English language proficiency (speaking, writing documents)

4. Areas Of Responsibility
a) Regulatory Affairs
 Preparation for regulatory submission for various countries
 Interpretation and implementation of Technical and clinical standards
 Writing testing protocols required for submissions
 Risk Management File
 Regulatory strategy preparation
 Regulatory assessment
 Regulatory review of Technical documents

b) Quality Assurance
 Establish and manage QMS from scratch
 Perform V&V on company’s products under development
 Handle S/W and other validations
 Contractor/Vendor management
 Define QC procedures
 Compilation of DHF and Technical Files.

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