We are seeking an experienced Regulatory Affairs professional with expertise in Clinical Evaluation Reports (CER), literature review, risk management, and Quality Management Systems for medical devices. The incumbent will be responsible for supporting global regulatory compliance activities, technical documentation preparation, and ensuring adherence to applicable regulatory standards and requirements.

Key Responsibilities

• Prepare, review, and maintain Clinical Evaluation Reports (CERs) for Class IIb and Class III medical devices in accordance with applicable regulatory requirements.
• Perform risk management activities in accordance with ISO 14971, including risk analysis, risk assessment, risk control, and benefit-risk evaluation.
• Support preparation and maintenance of technical documentation, design dossiers, and regulatory submissions.
• Ensure compliance with Quality Management System (QMS) requirements in line with ISO 13485:2016.
• Participate in internal and external audits and support implementation of corrective and preventive actions.

Qualifications & Experience

• Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, Medical Devices, or a related field.
• 3–8 years of experience in Regulatory Affairs for medical devices.
• Hands-on experience in preparing Clinical Evaluation Reports (CERs) for Class IIb and Class III medical devices.
• Strong experience in literature search methodologies and clinical data evaluation.
• Sound knowledge of ISO 14971 Risk Management processes.
• Working knowledge of ISO 13485:2016 Quality Management Systems.
• Familiarity with EU MDR 2017/745 and other international medical device regulations will be preferred.
• Strong analytical, documentation, and communication skills.

Key Competencies

• Regulatory Documentation & Compliance
• Clinical Evaluation & Literature Review
• Risk Management
• Technical Writing
• Quality Management Systems
• Attention to Detail
• Cross-functional Collaboration
• Problem Solving & Analytical Thinking