📢 Hiring Alert | Job Opening in Medical Devices Industry Position: Application for Medical Device Vigilance Specialist (Preferred Immediate Joiner) Location: Hyderabad Language Requirement: Fluent in Polish is must Key Responsibilities: Bachelor’s or master’s degree in pharmacy, Life Sciences, Biomedical Engineering, or related field. 2-4 years of experience in experience in complaint handling medical devices , Investigations, and/or Vigilance within a regulated industry (pharma or medical devices). Strong understanding of global regulatory requirements and standards (e.g., FDA QSR, ISO 13485, EU MDR, GVP). Experience with complaint management and safety databases (e.g., Track Wise, Aris, SafetyNet). Excellent communication skills (verbal and written). Strong analytical and problem-solving abilities. Ideal Candidate: Fluent in Polish and proficient in English . Experience in the medical devices or healthcare industry preferred. Excellent communication and documentation skills. Interested: Send your CV to sushmitha.r@4cpharma.com
Location: Hyderabad Work Mode: Work from Office Experience: 1–3 years Notice Period: Immediate Joiners / Up to 30 Days Industry: Medical Devices Key Responsibilities: Author and review clinical evaluation reports (CERs), clinical evaluation plans (CEPs), PMCF plans/reports, SSCPs, PSURs, and other safety documents for medical devices. Review safety data from clinical trials, post-market surveillance, complaints, and adverse events. Perform literature searches, data analysis, trend and hazard analysis, and summarize device-specific benefits and risks. Collaborate with cross-functional teams (Regulatory, Clinical, QA, Medical Affairs) and participate in client/regulatory interactions. Ensure compliance with EU MDR (MEDDEV 2.7, 2.12 series, ISO 14155) and internal standards. Support audits, inspections, and responses to regulatory queries. Prepare training decks, process improvement initiatives, and maintain knowledge of current regulations (MDCG, IMDRF, etc.). Act as a mentor to junior writers and support team knowledge sharing. Preferred Skills & Experience: 1–3 years in medical device regulatory affairs or clinical documentation. Hands-on experience with PSURs, PMS reports, CERs, CEPs, PMCF, and MAUDE database. Strong understanding of medical device safety reporting and regulatory guidelines. Excellent analytical, writing, and communication skills; detail oriented. Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook). Education: Bachelor’s or Master’s in Pharmacy, Life Sciences, Nursing, or related fields. B.Tech/M.Tech in Biomedical, Electronics, Mechanical Engineering also considered.