Saint Paul, MN | Woodbury, MN | Barling, AR
Also known as: LisaWeik
3 years Elected Offical, Washington County Commissioner, District 5 6 years Medical Device Adverse Event Reporting experience (post-market surveillance) of FDA regulated products; 5 years Regulatory Affairs professional experience (formulate strategies for speed to market of implantable medical devices); Extensive verbal negotiation experience with US FDA; clinical trial endpoints, control devices, new blood and tissue-contacting biomaterial submission testing requirements 7 months Quality System experience developing business requirements for the conduct of international clinical trials involving medical devices Extensive experience preparing electronic regulatory applications Extensive cross-functional product team experience 3 years Occupational Health and Safety Regulatory Affairs Representative 8 years Medical Laboratory Technician experience in clinical settings Specialties Adverse event reporting in the Medical Device industry and Regulatory Affairs submissions to FDA for Class III medical devices.
