Profile Details

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Hire Madhu S.

India

USD 30 /hr

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submissions & lead auditor ISO13485

Profile Summary

Over 5 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, Surgical Instruments, Disposable Polymeric devices (from I.V Cannula to Haemodializer over a range of 47 devices), TENS devices, dental devices and novel software systems. Prepared and finalised several technical files for CE marking of Class I (Class Im and Class 1s) Class IIa, and IIb devices including all follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and notified bodies (including BSI, DNV and TUV SUD). Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, Bio-compatibility reporting, process validations, labelling and packaging). Prepared and finalised pre-sub activities with the FDA for novel dental devices in the design phase to establishing the required regulatory pathway. Achieved and maintained registration of products in a range of jurisdictions including India, EU, US, Canada, and UK. Total Expertise in the application of EU MDR 2017/745, ISO 13485 (certified lead Auditor), ISO 14971, FDA 21 CFR Part 820, ISO 10993 standards, ISO 11135, and ISO 11137 standards. Well-versed in the development of Regulatory Files, literature searches, clinical evaluations report as per MEDDEV 2.7.1 rev.4, predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Usability Engineering studies.

Subject Matter Expertise

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ Product Compliance
• ☆ Medical Devices
• ☆ Regulatory Affairs
• ☆ Medical Device Regulatory Writing

Services

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study, Fact Checking, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis

Work Experience

Deputy Manager - Regulatory and Quality Affairs

Technomed Solutions LLP

March 2020 - Present

Deputy Manager - Regulatory and Quality Affairs

Vitromed Healthcare

August 2017 - December 2019

Regulatory and Quality Affairs Specialist

Elexes Medical Consulting Pvt. Ltd.

January 2015 - September 2016

Education

Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)

James Lind Institute, India

January 2020 - July 2021

Post Graduate Diploma in Food Safety & Quality Management

Indira Gandhi National Open University, New Delhi

July 2017 - May 2019

Masters in English Literature

Karnataka State Open University

July 2009 - May 2011

Masters in Science - Biotechnology

University of Mysore

July 2006 - May 2008

Bachelors in Science - Biotechnology

University of Mysore

July 2003 - May 2006

Certifications

• BSI Lead Auditor for ISO 13485:2016

  BSI training India

  April 2018 - April 2018