Harini O K

About Harini O K

I\'m fueled by a passion for the exciting intersection of medicine and engineering, and…

Experience

1. Regulatory Affairs Executive

   Morulaa Healthtech Pvt. Ltd

   Jun 2024 — Present · Chennai, IN

   As a Regulatory Affairs Executive, I specialize in managing medical device registrations and ensuring compliance with MDR 2017 regulations. With expertise in handling regulatory submissions, post-approval changes, and endorsement applications.Key Skills:Regulatory Knowledge: Expertise in MDR 2017 and CDSCO guidelines. Knowledge of regulatory forms such as Form MD-14, MD-15 and related device registration and licensing processes.Document Preparation & Submission: Proficiency in preparing regulatory dossiers and technical documentation (including Device Master Files, Plant Master File, Device specification sheets, and Design Dossiers).Regulatory Submissions and Amendments: Proficient in using the Sugam Portal for regulatory submissions, handling Post-Approval Change (PAC) applications, and managing endorsement applications for amendments in licensing and compliance.Query Management: Handling Queries from Regulatory Authorities: Ability to address and respond to queries from CDSCO and state licensing authorities regarding product registrations and submissions.Quality Management, Risk, and Compliance: Comprehensive knowledge of ISO 13485 and ISO 14971, with experience in medical device classification, risk assessments, and adherence to labeling/packaging standards as per MDR. Expertise in preparing Clinical Evaluation Reports (CER), conducting post-market surveillance, and reporting adverse events.Data Foldering & Management: Proficient in organizing and managing regulatory data files and documentation for efficient retrieval and compliance.Client Communication: Strong communication skills for effective interaction with clients to address inquiries, provide updates, and ensure alignment on regulatory requirements.AI in Regulatory Affairs: Experienced in utilizing AI tools, including the creation of GPT bots, to streamline regulatory processes, enhance data analysis, and improve query management.

Education

• National Public School

  High school

  2018 — 2020

• Jawahar Vidyalaya, Chennai

  Middle School

  2008 — 2018

• Rajalakshmi Engineering College

  Bachelor of Engineering - BE

  2020 — 2024