Device QARA Engineer

 
EDUCATION and/or EXPERIENCE
Bachelor’s degree or higher in a scientific or mechanical engeenering discipline; and at least 5 years related experience in a direct quality and regulatory role in a drug delivery products , preferbaly infusion pumps .extensive knowledge of applicable regulations including EU and US.
face=Helvetica size=2> ability to effectively communicate with and positively influence people.
 
 
Primary purpose and function of this position:
Lead & Support regulatory and quality aspects of device and drug/device combination elements  throught the einter product life cycle .
Support Regulatory strategy for development and submission .
Review device related protocols/reports to ensure compliance with the regulatory demands (for example: review risk analysis file, ensure that it gives answer to FDA expectations, review usability specification – ensure that it follows the standard guidelines, etc.)
Lead all product compliance activity: Applicable standards, directives and guidances
Monitor all design control activities .
 
Required Education & Experience
BS in engineering or equivalent.
5+ years QA and RA experience in supporting a medical device development and manufacturing environment.
 
Required Knowledge, Skills & Abilities:
Working knowledge of QSR’s, ISO 13485, MDD/MDR, MDSAP, and FDA requirements and standards.
Strong interpersonal, communication, analytical and complex problem solving skills.
The ability to develop partnerships and influence.
Ability to work independently and has strong team building skills.