Clinical Evaluation Specialist

A company is looking for a Principal Clinical Evaluation Specialist to join their Medical Affairs Group remotely. Key Responsibilities Author clinical documentation, including Clinical Evaluation Reports (CERs) and supporting documents Conduct comprehensive literature searches and stay informed about clinical landscapes and trends Manage timelines for CER development and interact with cross-functional teams for regulatory submissions Required Qualifications Bachelor's degree in a scientific or engineering field 10 years of experience in a medical or scientific setting At least 3 years of direct experience in CER writing Expertise in medical device regulations (MEDDEV 2.7.1, MDR, PMA, 510K, IDE) Strong experience in conducting literature reviews and protocol development for regulatory submissions

Mar 13, 2025 - 15:19
 0
Clinical Evaluation Specialist
A company is looking for a Principal Clinical Evaluation Specialist to join their Medical Affairs Group remotely. Key Responsibilities Author clinical documentation, including Clinical Evaluation Reports (CERs) and supporting documents Conduct comprehensive literature searches and stay informed about clinical landscapes and trends Manage timelines for CER development and interact with cross-functional teams for regulatory submissions Required Qualifications Bachelor's degree in a scientific or engineering field 10 years of experience in a medical or scientific setting At least 3 years of direct experience in CER writing Expertise in medical device regulations (MEDDEV 2.7.1, MDR, PMA, 510K, IDE) Strong experience in conducting literature reviews and protocol development for regulatory submissions