Description
My client a global leading origination is seeking a Regulatory Affairs Project Manager to join their team.
As the Regulatory Affairs Project Manager you be the interface between the European Post Market Surveillance team and the working groups involved in critical reviews of templates documents like CER, PMS plan, PMS report, PSUR and CEP.
Key skills and experience
*Detailed experience as a Regulatory Affairs Project Manager.
*Experience with Support with EU MDR, MDSAP, ISO into the company Quality System.
*Supporting critical review of processes and procedures in order to simplify, standardise and lean processes and with the objective to integrate better active PMS into the product life cycle.
*Experience with audit readiness.
*Critical review of designated Risk Management.
*Post Market Surveillance from the Quality System and the process point of view.