Regulatory Writer: PMCF Survey Protocol & CSR Medical Writer

Healthminds Consulting; Bengaluru; Vor Ort; INR 900.000 - 1.500.000; Vollzeit

Zusammenfassung

HealthMinds Consulting Private Limited is seeking a Regulatory Writer to develop PMCF survey protocols and CSRs for medical devices in line with EU MDR requirements. You will shape study objectives, endpoints, data collection plans, and analysis approaches, while ensuring quality and regulatory compliance.

The role involves collaboration with regulatory, clinical, biostatistics, and client teams, performing literature reviews, and finalizing documents such as PMCFERs, CERs, PMS reports, PSURs

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Scientific writing

Literature review

Data interpretation

Stakeholder communication

Ausbildung

Advanced degree in Life Sciences / Pharmacy / Biotechnology / Biomedical Sciences / Public Health

Jobbeschreibung

HealthMinds Consulting Private Limited | Full time

Regulatory Writer: PMCF Survey Protocol & CSR Medical Writer

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.