Philips

Regulatory Affairs Specialist

Deloitte

Providing subject matter and/or technical expertise to the study team.
Reviewing and analyzing information provided by the client and/or developed by the study team.
Applying analytical frameworks and methodologies to guide primary and secondary research.
Assisting in tracking and enforcement of project deadlines and schedules.
Shares acquired skills with team members through formal and informal channels.
Leads testing efforts.
Analyzing data using both quantitative and qualitative methods.

Senior Consultant

Valtech (India) Software Services Pvt Ltd

Sr SOFTWARE ENGG.

adea

I don't believe in any word that captures the essence of "PROFESSIONALISM"; instead, I believe "efficiency surpasses experience."

Specialities: 
Code of Federal Regulations (part 11, 820), 
ISO 13485 Internal Auditor, IEC 62304, Computer System Validation, Risk Management (ISO 14971), Secure by Design (Cybersecurity), GDPR, HITRUST Framework, Non-Product Software System Validation (NPSS), Computer System Validation (CSV), Failure Mode and Effects Analysis.

EAI, JCAPS,  Seebeyond, Mirth Connect (Long suit), Saddle, HL7-2.x, RxNorm, LOINC, ATC, Functional and technical aspects of Value based care (VBC), RRU (Relative Resource Utilization),

Taplio

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