Medical Officer

Job Description

Role Summary:

The Medical Officer supports medical writing, clinical evaluation, safety surveillance, and regulatory activities for medical devices, ensuring compliance with applicable regulations and contributing to product safety and performance throughout the product lifecycle.

Key Result Areas:

1. Medical Device Medical Writing

• Medical Writing - Authoring, updating, and reviewing, medical device focused documents in Regulatory and Safety Space
• Clinical Evaluation Plans (CEP)/ Reports (CER)
• Post-Market Clinical Follow-Up (PMCF) plans/reports
• Clinical Investigation Plan (CIP)/Protocol
• Clinical Study Reports (CSRs)
• Summaries of Safety and Clinical Performance (SSCP)
• Informed Consent Documents (ICD)
• Investigators Brochure (IB)
• Periodical Safety Update Reports (PSUR)
• Publication and white papers
• Health Hazard Analysis (HHA) / Evaluation (HHE) or Public Health Threat Analysis (PHTA) for Medical Device complaints
• Individual Case Safety Reports Narratives
• Other pertinent documents
• Literature Science: Literature search strategy, conduct, summary and reports
• Preparation of Literature search protocol and search strategy
• Conducting systematic literature searches to gather clinical data, evaluating evidence, and extracting data for inclusion in reports
• Preparation of Literature summary reports and Literature-based documents such as SotA

2. The Safety Associate for materiovigilance and post-market vigilance

• Individual Case Processing: Individual Case Safety Reports (ICSRs) of adverse device incidents and participation in complaint investigations
• Medical Coding – DPT Coding and Medical Events Coding
• Safety Reporting: Generation of human consequence reports of the complaints reported, which have incidents, near incidents of event of interest or procedural complications etc.
• Signal Detection: performing trending analysis, Monitoring Complaints, ADIs, safety literature and databases to identify potential safety risks or new risks associated with the device.
• Follow-up: Communicating with healthcare professionals to gather additional information on adverse events.

3. Organizational responsibilities

• Regulatory Compliance: Ensuring all documents adhere to India MDR, EU MDR, ISO 13485, other regulatory requirements and company's standard operating procedures (SOPs).
• Collaboration: Working with Regulatory Affairs, Quality, and R&D teams to align clinical data with safety and performance requirements.

Required Qualifications & Skills:

• Education: Medical Graduation – only MBBS or BHMS candidates may apply. Exceptionally good Pharm D candidates who have exposure and understanding of Medical Devices may be considered.
• Experience: 0-3 years of experience in Medical Devices Safety Functions or Medical Writing
• Knowledge: Deep understanding of EU MDR requirements, literature search methodologies, and clinical data interpretation.
• Skills: Exceptional writing/editing skills, Proficiency in English, understanding of French / Portuguese is an added advantage attention to detail, and proficiency in MS Office (Word/Excel), strong analytical thinking