Profile Details

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Hire Ranjith P.

United Kingdom

USD 75 /hr

Medical Device Regulatory (Expert in Creating Technical documentation as per MDD 93/42/EEC/MDR 2017/745, CE marking)

Profile Summary

• Prepare Technical documentation for Medical Device CE marking • Support MDR Compliance execution by reviewing/updating/creating Technical documentation to comply with EU MDR 2017/745 for Class I, Class IIa, Class IIb medical devices • Identify, review, update Medical device labelling to comply with MDR 2017/745 requirements. • Conduct gap analysis to identify gaps in Medical device Technical Files • Experience of submitting technical documentation for product registrations within Asia Pacific, Middle East & Africa, Central & Eastern Europe and Latin America •Timely preparation and submission of Regulatory documentation to register products as per International Regulations and country-specific requirements • Experience of communicating with Notified bodies and Regulatory authorities • Supporting compliance activities for Technical file audits • Review and update of Regulatory procedures for compliance with MDR 2017/745 • Experience of compiling and managing technical files in accordance with the MDD 93/42/EEC • Preparing Technical files for 510 (k) submissions • Review and update Technical file format for Annex II List A and List B IVD Medical Devices to ensure compliance with In-Vitro Diagnostic Medical Device Regulation IVDR 2017/746 • Good knowledge of regulatory frameworks (MDD 93/42/EEC, MDR 2017/745, CE marking), GMDN codes and ISO standards

Subject Matter Expertise

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

Services

• Writing

Writing Technical Writing

Work Experience

Regulatory Affairs Specialist

BD (Becton Dickinson)

January 2019 - Present

Regulatory Affairs Specialist

Zimmer Biomet

September 2018 - December 2018

Regulatory Affairs Specialist

Abbott

December 2017 - June 2018

Regulatory Affairs Consultant

SLE ltd

August 2017 - November 2017

Senior Regulatory Specialist

Johnson and Johnson

August 2015 - August 2017

Regulatory Affairs Specialist

ArjoHuntleigh

July 2014 - July 2015

Regulatory Affairs Associate

BTG

December 2012 - July 2014

Regulatory Affairs Associate

GE Healthcare

January 2011 - November 2012

Education

Masters Degree

University of Hertfordshire

September 2007 - June 2009

Bachelors of Technology (Biotechnology)

JNT University

September 2003 - July 2007

Certifications

• Certification details not provided.