Manju Sahu
MS Regulatory Affairs | Medical Devices, Documentation, Clinical Workflows, Safety & Usability | Quality-Focused, Patient-Centered RA Professional with experience shaping early-stage regulatory strategy
- Role
- Regulatory Affairs Intern at Corista
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Manju Sahu
What excites me the most?Turning innovative healthcare ideas into safe, compliant, real-world solutions that actually impact patients.I’m a Regulatory Affairs & Quality professional who loves working where clinical workflows, medical devices, and real patient safety meet. Currently pursuing my M.S. in Regulatory Affairs at Northeastern University, I thrive in roles where learning, building, and problem-solving intersect.Here’s what makes me stand out: I turn complex processes into clear, usable systems - from SOPs to design control templates to QMS documentation.🩺 I understand clinical workflows and can evaluate device behavior against real-world use cases. I’ve supported FDA Pre-Subs, risk management files, and device documentation for early-stage medtech programs.🤝 I communicate effectively across R&D, clinical, and quality teams with a safety-first mindset.My passion sits at the intersection of regulatory strategy, device/software testing, clinical workflows, and patient-centered design.If your work focuses on improving healthcare or advancing medical technology, I’m open to professional conversations that align with my background.
Experience
Regulatory Affairs Intern
Jan 2026 — Present · Concord, MA, US
Support regulatory activities for Software as a Medical Device (SaMD) used in digital pathology image management software.• Assist the regulatory team with FDA 510(k) documentation and submission support.• Help maintain Quality Management System (QMS) documentation aligned with ISO 13485 and ISO 27001 standards.• Support Computer Software Assurance (CSA) documentation and validation activities for regulated software systems.• Collaborate with cross-functional teams to support regulatory compliance throughout the product lifecycle.
Education
Northeastern University
Master of Science - MS, Regulatory affairs
2024 — 2026
Gujarat Technological University (GTU)
Diploma, Pharmacy
Gujarat Technological University (GTU)
Bachelor, Pharmacy
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