Clinical Project Manager

Vacancy expired!

Title : Clinical Project Manager

Location : Irvine, CA

Duration : 6+ months contract

Qualification:

• Program Manager to help with clinical evaluations in cardiac rhythm management division
• Bachelors degree in scientific, technical or medical field minimum, (Masters degree scientific or technical background or MD or PhD preferred)
• Project Management experience is a plus Med device experience (class III implantable strongly preferred) or pharma with regulatory background required
• Regulatory experience for FDA / EU guidance, directives and regulations
• Candidates familiar with med dev 2.7-1 revision 4 aim DD, EU MDR 2017-745 and guidance documents MDCG (medical device coordination group)
• Manage CEP, CERs, PMF, PMCF, SFCP (will work with writers or 3rd party to create these documents) - these are clinical deliverables for EU MDR submissions, good data analysis experience and ability to critique to ready reports for submissions Top Skills: regulatory experience with FDA and EU guidance, experience managing projects (timelines, deliverables, resource planning), experience writing and/or managing deliverables for clinical evaluations (CEP, CERs, PMF, PMCF, SFCP) preferred higher education

Vacancy expired!