Hiring For Quality Assurance & Regulatory Affairs
Role: Senior QA/RA Executive
Experience:
3+ years of experience IVD/ Pharma Industry
Job Description
Interaction with regulatory agencies
Prepare, review, file, and support premarket documents for global registrations
Collaborate with sales team to support marketing authorizations
Preparation of document packages for international regulatory submissions
Shall perform internal audit as per ISO 13485, MDSAP, USFDA, EU IVDR and IMDR requirements
Performing gap analysis, remediation/preparation, submission of documents are per EU IVDR 2017/746.
Manage and coordinate the works along with QA and RA team members.
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