Rahul Ravi Raj
Regulatory Affairs Intern (XN project) @ Cairn Diagnostics | Actively Seeking Full time opportunities in Regulatory Affairs and Quality Assurance | Northeastern University, Boston, - MS in Regulatory Affairs 2025
- Role
- Regulatory Affairs Specialist i - Post Market Surveillance (Capstone) at Tecomet, Inc
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Rahul Ravi Raj
As a Regulatory Affairs Intern (XN Project) at Cairn Diagnostics, I collaborated with the regulatory operations team to support De Novo reclassification activities and submission strategies. I applied my expertise in FDA Premarket Approval (PMA) and De Novo reclassification to optimize regulatory processes, enhance compliance, and expedite market access. Prior to this, I interned at LIFEPharma, where I monitored production processes for 3 major product lines, conducted over 20 inspections, and evaluated the performance of over 10 pieces of production equipment. I hold a Master\'s degree in Regulatory Affairs from Northeastern University and a Bachelor of Pharmacy from Manipal Academy of Higher Education. I am passionate about ensuring the safety and efficacy of pharmaceutical products and medical devices, and I am committed to continuous learning and professional development.
Experience
Regulatory Affairs Specialist i - Post Market Surveillance (Capstone)
Apr 2025 — Present · US
Maintaining and revising the PMS Plan Complaints Analysis Database and supporting PSUR development for devices under design control ensuring up-to-date compliance documentation • Leading annual PMS reviews by analyzing complaints sales and feedback driving identification of emerging risks CAPAs and quality enhancement opportunities• Integrating PMS outcomes into Risk Management CERs and CAPA systems enhancing regulatory preparedness and audit readiness • Partnering with R&D and Quality teams to incorporate real-world use data and design insights into surveillance efforts strengthening product lifecycle oversight.
Education
Northeastern University
MS in Regulatory affairs
2023 — 2025
Manipal Academy of Higher Education
Bachelor of Pharmacy - BPharm
2019 — 2023
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