Gayatri Yerawar
Product Risk Management Specialist | Medical Devices | Healthcare | DHF Remediation | Design Control | 21 CFR 820 | ISO 13485 | ISO 14971 | ISO/TR 24971 | EUMDR
- Role
- Risk Specialist at Philips
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Gayatri Yerawar
Around 7 years of professional experience in medical product life cycle management- As a Risk Engineer, Patient Safety and Quality is the top most priority- Proficient in Pre and Post market risk assessment activities - Hands-on experience of remediating Risk Management File for 15+ medical devices- Performs Complaint Analysis actvity to calculate observed risk in the field - Presents the issue to correction and removal board to take field action- Exposure of Design Input, Design Output, Design Review, Design Verification & Validation activities - Hands-on experience in creation of Requirements Specifications, Compliance Gap Analysis, Risk Management File, Usability Specification, Design Verification & Validation protocols and reports and Maintaining the Traceability Matrix- Experience of working on risk management activities for Class electromechanical medical devices- Review of CEP, CER, PMS, PMCF, PSUR- Proficient in DHF Remediation- Excellent document reviewer for submitting errorless deliverables- Timely delivery, Task ownership, Detail oriented approach are significant skills- Knowledge of 21 CFR 820, ISO 13485, ISO 14971, ISO/TR 24971, IEC 62304, IEC 62366, EU-MDR- Tools : Agile, SAP, JAMA
Experience
Risk Specialist
Oct 2024 — Present · Pune, IN
Supporting Pre and Post market risk assessments
Education
Mahatma Gandhi Mission's College of Engineering, Nanded
Bachelor of Engineering , Electronics and Telecommunication
Centre for Development of Advanced Computing (C-DAC)
PG Diploma
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