Clinical Affairs Project Lead
Core
Plan, execute, and deliver clinical affairs activities to generate and maintain clinical evidence supporting global market access and product lifecycle management for medical devices and IVD.
Role type
Senior Clinical Affairs Project Lead
Builds
Clinical evidence packages, Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) plans and reports, and scientific study protocols.
Domain
Medical Devices / In Vitro Diagnostics (IVD) / Life Sciences
Required skills
Clinical evaluation, medical writing, regulatory compliance (EU MDR, FDA, China), risk management documentation, study design, data interpretation, cross-functional stakeholder management
Preferred skills
End-to-end clinical trial execution, Good Clinical Practices (GCP) training, statistics
Technologies
EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, MDCG guidance, ISO 14971
Responsibilities
Author CEP and CER in accordance with global regulations; develop and maintain PMCF Plans and Evaluation Reports; support clinical studies and scientific evidence generation; drive process improvement and ensure compliance with regulatory and ethical requirements.
Seniority
Senior, hands-on IC