Medical Device Re Registration
Needed: project leader to lead a team of subject matter experts in reviewing and preparing for medical device regulatory re-registration activities at one of our well-established clients. required skills: · ability to lead a team of subject matter experts. · ability to manage complex regulatory and technical compliance issues. · ability to clearly discern and assess complex regulatory submissions. · experience in leading complex cross-functional projects. · robust technical writing skills tasks: · collect and coordinate information for active design dossiers and technical files into the sted format and advise on the submission strategy. · create and maintain product technical files, clinical evaluation reports and regulatory submission dossiers. · review labeling and labels, product codes, legal manufacturers, and classifications for compliance with us and eu requirements. · review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws. · review changes to existing products and sops to define the requirements for regulatory submissions. · responsibility for timely registrations. education and experience: · 15+ years of experience in regulatory affairs and compliance · leading projects and directing strategies for medical devices, biologics, and/or pharmaceutical · minimum bachelor’s degree in a scientific or technically related field. · knowledge of the global regulatory approval processes and requirements · experience with class ii and ii medical devices is mandatory. · excellent project management skills. · high level of integrity. · strong problem solving and communication skills.
Anne |Zintro Expert
I just wrote you a letter for a medical device Reg affairs position. It looks like this is also with...1.2 Hours Later
Hello Ziafef2ddd Happy New Year. I always find it difficult to write to a a symbolic tie. I am inte...2 Hours Later
Umberto |Previously: COO, VP & Director Regulator
Dear Inquirer, I have been *****lved in leading projects, *****tegies, developing...2.2 Hours Later