Regulatory Writer: PMCF Survey Protocol

HealthMinds; Bengaluru; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

HealthMinds in Bengaluru seeks an experienced Regulatory Writer to develop PMCF survey protocols and CSRs for medical device regulation. You will craft study objectives, endpoints, methodologies, data collection plans, and analysis approaches to generate Level IV evidence under EU MDR guidelines.

Key tasks include literature reviews, PMCFERs, CERs, PSURs, and collaboration with regulatory, clinical, and biostatistics teams.

Qualifications

• Advanced degree in Life Sciences or related field with strong writing skills.
• Experience in medical writing, clinical evaluation, PMCF or regulatory documentation.
• Knowledge of PMCF, CER, PMS, PSUR and RWE concepts and regulatory requirements.

Responsibilities

• Develop PMCF survey protocols including objectives, endpoints, methodology and data collection plans.
• Design survey questionnaires and tools to collect real-world post-market data.
• Generate and evaluate Level IV evidence from PMCF surveys and observational data.
• Analyze survey results and prepare CSRs with clear methodology and conclusions.
• Support PMCFERs, CERs, PMS reports, PSURs and benefit-risk assessments.
• Perform literature reviews to support study rationale and findings interpretation.
• Collaborate with regulatory, clinical, biostatistics and client stakeholders to finalize documents.

Skills

Scientific writing

Literature review

Data interpretation

Stakeholder communication

Education

Advanced degree in Life Sciences or related field

Job description

Regulatory Writer: PMCF Survey Protocol CSR Medical Writer

Role Summary Support the development of Post-Market Clinical Follow-up (PMCF) survey protocols and Clinical Study Reports (CSRs) to generate and document Level IV clinical evidence for medical devices in compliance with EU MDR requirements.

Key Responsibilities:

• Develop PMCF survey protocols, including study objectives, endpoints, methodology, inclusion/exclusion criteria, data collection plans, and analysis approach.
• Design survey questionnaires and other tools for collection of real-world, post-market clinical data.
• Generate and evaluate Level IV evidence from PMCF surveys, physician/user feedback, and observational post-market data to support device safety, performance, usability, and clinical benefit.
• Analyze survey results and prepare Clinical Study Reports (CSRs) with clear presentation of methodology, findings, conclusions, and limitations.
• Support PMCF Evaluation Reports (PMCFERs), Clinical Evaluation Reports (CERs), PMS Reports, PSURs, and benefit-risk assessments.
• Perform literature reviews and evidence assessments to support study rationale and interpretation of findings.
• Collaborate with regulatory, clinical, biostatistics, and client stakeholders and address review comments through document finalization.
• Ensure compliance with EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, MDCG guidance, ISO 14155, and internal quality processes.

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, Public Health, or related field.
• Experience in medical writing, clinical evaluation, PMCF, CER, clinical research, or medical device regulatory documentation.
• Strong scientific writing, literature review, data interpretation, and stakeholder communication skills.
• Knowledge of PMCF, CER, PMS, PSUR, real-world evidence (RWE), and medical device regulatory requirements.