Rafaella Khudaverdyan

Available to hire

Skills

Experience Level

Language

Armenian
Fluent
English
Fluent
Russian
Fluent
German
Advanced
Spanish; Castilian
Beginner

Work Experience

Senior Regulatory Affairs Specialist / Acting Regulatory Affairs Manager at DePuy Synthes (Johnson & Johnson)
September 1, 2021 - Present
Lead EU MDR and Swissmedic regulatory submissions ensuring continuous market access across Switzerland, EU, and global markets. Prepare and maintain MDR Technical Documentation (Annex II & III) and lifecycle documentation. Act as authorized first signatory for Declarations of Conformity, Letters of Authorization, and Free Sales Certificates. Collaborate with QA, R&D, Supply Chain, and Commercial teams. Maintain regulatory systems using SAP and Windchill.
Regulatory Affairs Specialist at ClinChoice LLC
October 1, 2020 - May 1, 2021
Led EU MDR and CE compliance activities for medical devices. Acted as primary regulatory contact with Notified Bodies (BSI, TÜV). Maintained regulatory trackers, databases, and ISO 13485-aligned SOPs. Supported post-market regulatory commitments.
Regulatory Affairs Specialist at FMD K&L
April 1, 2017 - September 1, 2020
Managed full regulatory lifecycle activities for pharmaceuticals and medical devices. Prepared marketing authorizations, renewals, and variations. Coordinated multilingual labeling, IFUs, and packaging materials.

Education

Certified Project Management (CPM) at Swiss School of Business and Management, Geneva
January 1, 2024 - January 1, 2025
MSc in Pharmacology at Yerevan State Medical University
January 1, 2016 - January 1, 2017
BSc in Pharmacology at Yerevan State Medical University
January 1, 2012 - January 1, 2016

Qualifications

Certified Project Management (CPM)
January 1, 2024 - January 1, 2025

Industry Experience

Healthcare, Life Sciences, Manufacturing, Professional Services, Other

Skills

Experience Level

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