JOB DETAILS

You will plan and lead regulatory affairs, including preparing submissions for clearances and registrations. 
You will serve as Management Representative for the company’s FDA QSR and ISO 13485-compliant quality system, responsible for procedures and policies that meet the requirements of our target markets. 

You will be a liaison with government and regulatory officials in obtaining product approvals. 

You will provide leadership and, with your team, training programs for the organization to ensure that colleagues integrate quality system methods into product development.

You will collaborate with the team and external clinical advisors to craft test plans that provide the necessary clinical validation of company technologies.
FUNCTIONAL AREA
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