Clinical Affairs Specialist Pharma & Medical Devices

Job Description

Job Summary: We are seeking a highly motivated and detail-oriented Clinical Affairs Specialist with strong experience in post-market surveillance, Post-market Clinical Follow-up (PMCF), Periodic Safety Update Reports (PSUR), clinical evaluation under MDR, and health complaint assessment within the pharmaceutical and medical device industry . The ideal candidate will support regulatory compliance and safety monitoring in alignment with US FDA, EU MDR and relevant global regulatory standards. Key Responsibilities: Prepare and manage Post-Market Surveillance (PMS) activities for pharmaceutical and medical device products. Prepare and update Post-market Clinical Follow-up (PMCF), Periodic safety update report (PSUR) in compliance with EU MDR and other relevant regulations. Conduct and compile Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) as per MDR (EU) 2017/745 requirements. Review, assess, and investigate health complaints, adverse events, and product safety issues. Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, and other relevant department. Maintain up-to-date knowledge of global regulatory requirements related to PMS, PMCF, PSUR, and clinical evaluations. Support audits and inspections related to PMS, PMCF, PSUR, and health complaint documentation. Ensure accurate documentation and timely submission of regulatory reports. Other tasks as assigned by management. Qualifications & Requirements: Bachelor's or Masters degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field. Minimum 5-7 years of experience in clinical affairs, regulatory affairs, or related function in the pharmaceutical or medical device industry. In-depth understanding of EU MDR (2017/745), ISO 14155, and applicable regulatory guidelines. Strong experience with PSUR preparation, PMS plans/reports, and clinical evaluation documentation. Familiarity with health complaint management systems and risk assessment methodologies. Excellent written and verbal communication skills. Ability to work independently and manage multiple projects. Preferred Skills: Experience working with Notified Bodies and regulatory agencies. Prior involvement in MDR transition projects. Knowledge of pharmacovigilance and medical device vigilance systems