Regulatory Affairs Executive

Job Description

Education : UG: B Tech in Mechanical, BSc, B. Tech Medical Science, M sc. Key skills: Regulatory Submissions : 510(k), CE Marking, EU MDR 2017/745, US FDA, Indian MDR 2017 Clinical Evaluation Reports (CER) : Development, Literature Reviews, Clinical Data Analysis Risk Management : ISO 14971, Risk Assessments, Risk Mitigation Strategies Post Market Surveillance (PMS) : Data Collection, Reporting, Device Performance Monitoring Post Market Clinical Follow-up (PMCF) : Study Design, Data Analysis, Reporting Regulatory Compliance : US FDA, EU MDR, Indian MDR, ISO 13485 Communication : Cross-functional collaboration, technical writing, regulatory guidance Desired Candidate Profile: Regulatory Affairs Executive with 3-4 years of experience in medical device regulation and compliance. Proficient in preparing and submitting regulatory filings for product approvals, conducting clinical evaluations, managing risk assessments, and ensuring post-market compliance across multiple regions. Experienced in EU MDR 2017/745, US FDA regulations, Indian MDR 2017, and ISO 13485 standards. Proven ability to collaborate with cross-functional teams to meet regulatory requirements and deliver high-quality documentation, including Clinical Evaluation Reports (CER), Post Market Surveillance (PMS) reports, and PMCF studies. Company Profile: One of the Leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and having manufacturing unit at Rai Industrial Area, District Sonipat, Haryana and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.