Clinical Evaluation Specialist
Clinical Evaluation Specialist
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Job Description
Job Title : Clinical Evaluation Specialist
Functional Area : Clinical Research and Regulatory Support
Reports To : Sr. Manager Clinical Trials
Division : Clinical Trials
Salary: 06 07 LPA
Key Accountabilities
Develop and author clinical evaluation deliverables such as Clinical Evaluation Plans (CEP) Clinical Evaluation Reports (CER) PostMarket Surveillance (PMS) plans/reports PostMarket Clinical Followup (PMCF) plans/reports and Summary of Safety and Clinical Performance (SSCP) reports in strict compliance with EU MDR 2017/745 and relevant global regulatory standards.
Critically evaluate and synthesize clinical evidence from various sources including clinical investigations scientific literature PMS/PMCF data and registries. This includes reviewing medical literature analyzing clinical risks and providing comprehensive benefitrisk assessments for medical devices.
Collaborate crossfunctionally with teams in Regulatory Affairs R&D Quality Assurance Sales and Marketing to ensure alignment on clinical evaluation project deliverables and support product development approval and postmarket activities.
Review and provide feedback on Instructions for Use (IFUs) patient guides clinical study protocols and clinical investigation reports to ensure consistency and compliance with regulatory requirements.
Manage responses to regulatory authorities (e.g. Notified Bodies and Competent Authorities) addressing complex queries related to clinical evaluations and ensuring compliance with EU MDR and other regulatory frameworks.
Ensure quality and integrity of documentation maintaining attention to detail consistency and adherence to regulations such as ISO 13485 ISO 14155 MEDDEV 2.7/1 Rev 4 and EU MDR 2017/745.
Support regulatory submissions by providing clinical evidence for product approvals indication expansions and ensuring compliance with postmarket surveillance and clinical followup obligations.
Stay current with global regulations and standards including MDR MEDDEV and ISO and effectively communicate the implications of evolving regulatory landscapes to internal stakeholders.
Key Measures
Indepth knowledge of EU MDR 2017/745 MEDDEV 2.7/1 Rev 4 and relevant ISO standards (ISO 13485 ISO 14155).
Excellent ability to critically appraise clinical data and present wellorganized scientifically sound reports.
Strong technical and medical writing skills with an ability to convey complex information clearly and concisely.
Experience with regulatory submissions and addressing Notified Body/Competent Authority queries is a plus.
Eligibility criteria
Advanced degree in life sciences biomedical engineering or a related medical/scientific discipline.
4 to 5 years of experience in clinical evaluation medical writing or a related role in the medical device industry with a focus on clinical evaluation documentation.
Proven experience in medical writing with a strong focus on clinical evaluation documentation for medical devices.
Employment Type
Full Time
