Medical Device Medical Officer

job descriptions for a Medical Device Medical Officer

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

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