Job descriptions

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

1. 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.

1. 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), solid analytical thinking

Job Snapshot

Updated Date

26-08-2026

Job ID

JOB11020

Sub Function/POD

MedTech Office

Location

Zydus Medtech Private Limited|ZMPL Office, Ahmedabad, Gujarat, India

Employee Type

P-P8-Probationer-HO Executive

📌 Medical Officer (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad