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
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