Pori Saikia
Bangalore
Summary
Experienced Regulatory Affairs and Post-Market Surveillance Specialist with over 3 years and 8 months in the medical device industry. Skilled in FDA MDR submissions, complaint handling, ISO 13485, and regulatory compliance for Class I/II/III devices. Proven ability to lead surveillance initiatives, manage client expectations, and support audit readiness.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Senior Associate – Regulatory Affairs / QA
Genpact (Client: Olympus)
Bangalore
08.2024 - Current
- - Prepared and submitted FDA Medical Device Reporting (MDR) Form 3500A ensuring compliance with regulatory timelines and accuracy.
- - Collaborated with cross-functional teams for data gathering and documentation.
- - Maintained detailed MDR logs for regulatory audits and inspections.
Senior Associate – Complaint Handling Specialist
Wipro (Client: Philips)
Kolkata
01.2022 - 07.2024
- - Led post-market surveillance efforts including complaint triaging and damage coding.
- - Worked on high-risk device categories and ensured timely case resolution.
- - Trained and mentored team members on complaint processing standards and client SOPs.
- - Ensured compliance with client KPIs and FDA guidelines.
Education
M.Tech - Bioelectronics
Tezpur University
01.2021
B.Tech - Biomedical Engineering
North-Eastern Hill University
01.2019
Skills
- Regulatory Submissions: FDA Form 3500A, E-Submitter
- Post-Market Surveillance: Complaint Handling, Vigilance, MDR reporting, Damage Coding
- Compliance & Standards: ISO 13485, QMS
- Tools & Platforms: SAP Life Sciences, Trackwise, Power BI, Microsoft Office
- Soft Skills: Attention to detail, Cross-functional collaboration, Client management
Certification
Advanced Program in Clinical Research & Management (Ongoing)
Timeline
Senior Associate – Regulatory Affairs / QA
Genpact (Client: Olympus)
08.2024 - Current
Senior Associate – Complaint Handling Specialist
Wipro (Client: Philips)
01.2022 - 07.2024
M.Tech - Bioelectronics
Tezpur University
B.Tech - Biomedical Engineering
North-Eastern Hill University
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