Regulatory Officer

Job Description:

Regulatory Affairs Executive - Medical Devices
Experienced Regulatory Affairs Executive with strong expertise in Medical Writing, EU MDR 2017/745 compliance, and regulatory documentation for Class IIb & Class III Implantable Intra Ocular Lens (IOL) devices. Skilled in handling Clinical Evaluation documentation, Technical Files, Risk Management, Post-Market Surveillance, and QMS documentation in line with international regulatory standards.

Core Responsibilities
Preparation and maintenance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class IIb & III Implantable IOL devices as per EU MDR 2017/745.
Development and management of Technical Files, Design Dossiers, and regulatory documentation for EU and CDSCO submissions.
Ensuring compliance with GSPR (General Safety & Performance Requirements) under EU MDR.
Preparation and maintenance of PMS, PMCF, and PSUR documentation.
Managing Risk Management Files in accordance with ISO 14971 and ensuring alignment with clinical evaluation and PMS activities.
Drafting and maintaining clinical trial documentation, including Protocols, CRFs, and ICFs, and coordinating with clinical trial centres.
Supporting prospective clinical trial documentation for Trifocal, Bifocal, and EDOF IOLs as per Chinese regulatory requirements.
Ensuring traceability between design verification, validation, and risk management documentation.
Preparation and maintenance of IFU, usability engineering files, labelling documentation, and compliance records.
Creating and controlling QMS documentation, including Quality Manuals, SOPs, Procedures, Work Instructions, and Formats.
Supporting country-specific medical device registrations and regulatory submissions.
Assisting in notified body audits (DNV), regulatory inspections, and internal compliance activities.
Collaborating with cross-functional teams to ensure audit readiness, product safety, and regulatory compliance.

Key Skills
EU MDR 2017/745
Clinical Evaluation (CEP/CER)
PMS / PMCF / PSUR
Technical File & Design Dossier
ISO 14971 Risk Management
Medical Writing
Clinical Trial Documentation
GSPR Compliance
QMS Documentation
CDSCO Registration
Usability Engineering
Regulatory Submissions & Audit Support