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
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 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
Define QC procedures
Compilation of DHF and Technical Files.