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ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
Our subsidary, M Squared Associates, is a consulting firm providing regulatory, quality systems and clinical research (CRO) services to US and international medical technology firms.
We have an immediate need for a Clinical Evaluation Report (CER) specialist with demonstrated expertise in medical devices, literature search methodologies, and the EU Medical Device Regulation (EU MDR).
The CER Specialist will work on a per project basis as a part of a multi-specialty project team responsible for a variety of client projects. This person will be responsible for CER writing activities in coordination with project teams, under the direction of our Senior Project Manager.
Essential Functions Include:
Review technical documentation and clinical data for incorporation into Clinical Evaluation Reports.
Perform literature searches in Embase and PubMed and screen literature citations for relevancy.
Summarize relevant literature and integrate with new or existing information to satisfactorily meet the EU MDR requirements for Clinical Evaluation Reports.
Qualified candidates must have:
Full Time
Wholesale
$99k-119k (estimate)
04/10/2023
06/07/2024
MIAMI, FL
50 - 100
1979
VICTOR G FARINAS
$5M - $10M
Wholesale