Device RA Manager

Primary purpose and function of this position:
· Lead & Support regulatory aspects of device and drug/device combination elements throught the einter product life cycle .
· Build Regulatory strategy for development and submission along the project
· 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
· Point of contact for the authorities – responsible to initiate the plan and the discussion in front of the authorities
Required Education & Experience
· BS in engineering or equivalent.
· 5+ years 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.
· An understanding of the principles of configuration management and document control.
Reports To: Director QARA