Headline

Regulatory affairs assistant officer | Medical devices | Certified advance clinical research and clinical data management course | QC supervisor Apperentice - stability studies | M.Sc. Chemistry.

About

I have of hands-on experience as an Assistant Officer in Regulatory Affairs for medical devices, where I gained strong knowledge of regulatory compliance, documentation, submissions and also certified ISO: 13485. In addition, I have completed a comprehensive course in Clinical Research and Clinical Data Management, which has equipped me with the skills to understand clinical trial protocols, data handling, and ethical guidelines. I also bring industry experience from my time as a QC Apprentice, where I gained practical exposure to quality control processes in a leading biopharmaceutical company. I am now looking to grow further in the regulatory by contributing to impactful projects in the healthcare sector.

Location

Bengaluru

Work experience

Assistant officer Regulatory Affairs at Futura Surgicare Pvt Ltd, Sep 2024 - Present · 1 yr 11 mos, Bengaluru, Karnataka, India, 1. Regulatory Compliance o Review and ensure compliance with regulatory requirements for medical devices. o Prepare and submit regulatory filings, including 510(k) submissions, CE marking, CDSCO, MDSAP and other international registrations. o Monitor regulatory changes and update internal stakeholders on implications for products and processes. o Conduct Post Market Surveillance, Post Market Clinical Follow up, Risk Management, Periodic Safety Update Report, Manage Product Safety, General Safety and Performance Requirements (GSPR), Essential Safety Requirements, Eudamed Registration. o Obtain test and manufacturing license from CDSCO. 2. Quality Assurance Support o Collaborate with Quality Assurance to ensure regulatory requirements are integrated into quality systems. o Assist in audits and inspections related to regulatory compliance. 3. Documentation Management o Maintain and manage regulatory documentation, including regulatory submissions, approvals, and correspondence with regulatory agencies. o Ensure accuracy, completeness, and timeliness of regulatory submissions and responses. 4. Strategic Regulatory Planning o Develop and implement regulatory strategies for new product development and product lifecycle management. o Provide regulatory guidance to cross-functional teams on regulatory requirements and timelines. o Stay updated on industry trends, regulatory changes, and best practices through continuous improvement

Apprentice at Biocon, May 2024 - Sep 2024 · 5 mos, Bengaluru, Karnataka, India, QC - Supervisor Apperentice Knowledge on Stability studies Migration of novatech to LIMS knowledge on chemical analysis of API small molecules

Education

Msc chemistry, Chemistry, Kuvempu University, Shankaraghatta, Shimoga