POSITION TITLE: Medical Writer

REPORTS TO: Global Clinical & PMS Specialist

LOCATION: Noida, India

PURPOSE OF THE ROLE

The Medical Writer is a key member of the Quality and Regulatory Affairs team at Global Capability Centre, Noida, a Gentell company. The role is responsible for preparing and maintaining Clinical Evaluation Reports (CERs), regulatory documentation, clinical affairs, and post-market surveillance (PMS) activities for medical devices across global markets.

The position ensures that products comply with applicable regulatory requirements and are supported by robust clinical evidence throughout the product lifecycle in accordance with International Organization for Standardization ISO 13485:2016, EU MDR 2017/745, UK MDR 2002 (as amended), MDSAP requirements, MEDDEV 2.7/1 Rev. 4, applicable MDCG guidance documents, and relevant clinical evaluation, post-market clinical follow-up (PMCF), and post-market surveillance guidelines and standards.

KEY RESPONSIBILITIES

Specific responsibilities include, but are not limited to:

1. Clinical Evaluation Report

- Preparation and maintenance of Clinical Evaluation Reports (CERs) in accordance with EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4 requirements.
- Preparation of Clinical Evaluation Plans (CEP), CERs, PMCF Plans, PMCF Evaluation Reports, and Summary of Safety and Clinical Performance (SSCP).
- Robust knowledge of applicable MDCG guidance documents related to clinical evaluation, PMCF, equivalence, and clinical evidence.
- Experience in conducting clinical literature searches, appraisal, analysis, and data synthesis.
- Ability to evaluate clinical safety, performance, and benefit-risk profiles of medical devices.
- Expertise in demonstrating clinical equivalence and state-of-the-art analysis (Conduct comprehensive reviews of current medical, clinical, and technological knowledge related to the device and intended use).

2. Literature Search Review (LSR)

- Conduct systematic literature searches in accordance with EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4,



and applicable MDCG guidance documents.
- Develop Literature Search Protocols and search strategies using appropriate keywords, Boolean operators, and inclusion/exclusion criteria.
- Perform scientific and clinical literature searches using databases such as PubMed, Google Scholar, Embase, and clinical trial registries.
- Screen, review, and appraise scientific publications for clinical relevance, safety, performance, and state-of-the-art evaluation.
- Prepare and maintain Literature Search Review (LSR) reports and supporting documentation.

3. Post-Market Surveillance (PMS)

- Development and maintenance of Post-Market Surveillance (PMS) Plans, PMS Reports (PMSR), and Periodic Safety Update Reports (PSUR).
- Collection, review, and trending of post-market data including complaints, adverse events, customer feedback, and vigilance information.
- Coordination and support of Post-Market Clinical Follow-up (PMCF) activities and associated documentation.
- Support trend analysis and identification of safety signals
- Assist in documentation and escalation of adverse events and field safety corrective actions (FSCAs)
- Integration of PMS outputs with Risk Management and product lifecycle activities.
- Knowledge of applicable PMS and vigilance requirements under EU MDR 2017/745 and relevant MDCG guidance documents.
- Strong analytical, technical writing such as usability report and risk management files, and documentation management skills.

4. Others

- Collaborate with Quality, Regulatory, Clinical, and R&D; teams to ensure alignment across product lifecycle activities




- Maintain awareness of evolving global regulatory requirements and guidance
- Support implementation of regulatory and clinical best practices
- Contribute to continuous improvement initiatives within Regulatory and Clinical functions
- Participate in training and development activities to enhance regulatory and clinical knowledge
- Support CAPAs, complaint investigations, and risk management activities
- Assist in internal audits and external inspections (Notified Body, UKCA, MDSAP, and customer audits)
- Maintain organized and compliant documentation systems
- Support communication with regulatory authorities, notified bodies, and external stakeholders as required

MINIMUM REQUIREMENTS / QUALIFICATIONS

Education & Experience:

- Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related discipline (or equivalent experience)
- Working knowledge of ISO 13485:2016, EU MDR 2017/745, UK MDR 2002 (as amended), and MDSAP requirements
- Understanding of EU MDR Annex II and III (Technical Documentation) and Annex XIV (Clinical Evaluation and PMS)
- Familiarity with clinical evaluation processes including CEP, CER, literature reviews, and clinical evidence strategies
- Knowledge of post-market surveillance (PMS) requirements including PMS Plans, PMS Reports (PMSR), and Periodic Safety Update Reports (PSURs)
- Understanding of vigilance reporting, adverse event reporting, and Field Safety Corrective Actions (FSCAs)
- Minimum 2–4 years of experience in Regulatory Affairs, Clinical Affairs, or a combined Regulatory/Clinical role in medical device industry.
- Experience supporting Technical Documentation, Clinical Evaluation, or PMS activities

EEO STATEMENT

We are an Equal Employment Opportunity Employer and do not discriminate against applicants based on race, age, religion, sex, sexual orientation, gender identity, disability, or any other protected characteristic.

Pay: ₹600,000.00 - ₹1,200,000.00 per year

Work Location: In person

📌 Medical Writer (India)
🏢 Gentell
📍 India