Clinical Project Manager # JN -042021-62843

Santa Clara, California
Industry: Business Analyst / Project Manager
Job Number: JN -042021-62843

Title                            : Clinical Project Manager

Location                    : Santa Clara, 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

 

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