Harini O K

Regulatory Affairs Executive @Morulaa Healthtech Pvt. Ltd

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.

National Public School

High school

Jawahar Vidyalaya, Chennai

Middle School

Rajalakshmi Engineering College

Bachelor of Engineering - BE