Open to opportunities

Rajan sharma

@rajansharma4

Message

I’m a QA/RA professional driving ISO 13485 and EU MDR Class III compliance.

India

Message

What I'm looking for

I’m looking for a QA/RA role in medical devices where I can own MDR/ISO documentation, support audits with strong evidence, and drive UDI/EUDAMED, risk management, and labeling compliance through efficient QMS processes.

I’m a QA/RA professional specializing in Class III medical device compliance with ISO 13485 and EU MDR 2017/745. I focus on regulatory documentation accuracy, audit-readiness, and disciplined QMS maintenance.

I’ve achieved “0 major non-conformities” across 2 internal audits and 2 external audits by keeping documentation updates and compliance controls on time. I also “significantly reduced documentation turnaround times” by streamlining document approval workflows.

In my Class III work, I’ve contributed to Technical File and Device Master File updates to support MDR Annex II and III compliance. I execute UDI/EUDAMED and labeling compliance (including EMDN mapping), maintain Declarations of Conformity, and support risk management file updates and PMS documentation review for vigilance alignment.

As a Merlin MD QA/RA Associate, I ensure MDR and ISO 13485 compliance through accurate document control and QMS maintenance. I prepare and manage evidence for internal and external audits, track CAPA/NCR effectiveness, and run periodic gap assessments to drive corrective actions and continuous improvement.

Experience

Work history, roles, and key accomplishments

Current

QA/RA Associate

Current

Merlin MD

Feb 2024 - Present (2 years 3 months)

Maintained ISO 13485 and EU MDR compliance through regulated document control and QMS maintenance, supporting internal/external audits with zero major non-conformities across 2 internal and 2 external audits. Streamlined document approval workflows to reduce turnaround time and contributed to Technical File/Device Master File updates and UDI/EUDAMED/labeling compliance for Class III devices.

ISO 13485 EU MDR Document Control CAPA And NCR Management Internal Audit UDI And EUDAMED Readiness Labeling & Coding (EMDN)Change Control

Senior Process Executive

Cognizant Technology Solutions India Pvt Ltd

Mar 2023 - May 2023 (2 months)

Improved clinicians' documentation accuracy and traceability by streamlining record review and entry workflows for high-volume clinical projects. Collaborated with medical staff to identify process gaps and ensured on-time delivery while maintaining compliance with data quality requirements.

Clinical Documentation Review Data Quality Assurance Record Entry & Validation Compliance Monitoring

Back End Executive

Cogito Tech Llc

Aug 2021 - Apr 2022 (8 months)

Enhanced clinical data quality by accurately classifying and labeling complex healthcare information to improve machine learning model performance. Summarized and structured medical case histories to support legal teams and led/trained ~25 members to strengthen SOP adherence and delivery accuracy.

Data Labeling Healthcare Data Structuring Data Quality Client Communication Workflow Management Prioritization

Education

Degrees, certifications, and relevant coursework

IILM College of Engineering and Technology, Greater Noida

Master of Technology, Biotechnology

2021 - 2023

Grade: 8.9 CGPA

Completed a Master of Technology in Biotechnology at IILM College of Engineering and Technology, Greater Noida (2021–2023), achieving a CGPA of 8.9.

IILM College of Engineering and Technology, Greater Noida

Bachelor of Technology, Biotechnology

2016 - 2020

Grade: 7.32 CGPA

Completed a Bachelor of Technology in Biotechnology at IILM College of Engineering and Technology, Greater Noida (2016–2020), achieving a CGPA of 7.32.