Create & maintain plans and reports for regulatory authorities, including but not limited to Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up Plans (PMCF-P), Post-Market Clinical Follow-up Reports (PMCF – R), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR). 1. Strong Clinical Evaluation experience, writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Follow Up Plan (PMCF P), Post Market Follow up Report (PMCF R), Summary of Safety Clinical Performance (SSCP), Periodic Safety Update Report (PSUR) .