Regulatory Engineer

Responsibilities

• Lead preparation of Compliance Data Reports (CDRs) and Test Report Forms (TRFs) to demonstrate compliance with IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417, eIFU Regulation (EU-2021 / 2226), EU MDR [2017 / 745], UKCA, Canadian (SOR / 98-282), and Australian (TGR) medical device regulations.​
• Analyze historical Request for Change (RfS) and design change data to develop and maintain regulatory compliance checklists and criteria for software medical device documentation.​
• Perform systematic gap assessments on change records and documentation to identify compliance risks, deficiencies, and areas for improvement per current regional and international requirements.​
• Develop, document, and execute remediation plans and associated Regulatory Affairs (RA) deliverables, such as updated DHF / technical files, risk management, usability, and labeling documentation.​
• Work cross-functionally with product development, engineering, quality, and clinical teams to embed compliance considerations into all processes.​
• Monitor ongoing global regulatory updates and proactively update internal processes and product files.​
• Support and lead internal audits, reviews, and preparations for external audits by notified bodies and competent authorities.
• Liaise with global regulatory agencies and notified bodies for submissions, clarifications, and product registrations as needed.​

Experience

Key Competencies

Educational Background

Bachelor's degree  Mechanical Engineering, Life Sciences, Computer Science, Regulatory Affairs, Biomedical Engineering

Advanced certifications (e.g., Regulatory Affairs Certification, ISO 13485 lead auditor, etc.) are a plus.​

Skills Required

iec 62304 , Risk Assessment, Change Management, Technical Documentation