Alexandra Gerhards Email & Phone Number

Denver, Co, Us

Denver, Colorado, United States

Denver, Colorado

Alexandra helps to provide clients with industry-leading regulatory and quality consulting and engineering services throughout the entire product life-cycle. The solutions R&Q provides aim to accelerate the success of medical device companies and improve people’s lives. Alexandra, as a part of the R&Q team, can help clients both small and large with strategic and tactical advice and support in regulatory affairs and quality assurance.

Boulder, Co

• Develop regulatory pathways (FDA, EU) including classification, submission pathway, and applicable standards and guidances• Put together regulatory submissions including FDA Q-Sub, 510(k), IDE, and EU Technical Documentation• Perform internal audits for company and clients (ISO 13485:2016 Lead Auditor certified); implement QMS procedures and processes; remediate non-conformances and deficiencies; aid in and act as company liaison for notified body audits • Generate non-conforming product reports; investigate failures and determine risk for disposition; generate corrective and preventive action reports; perform failure analysis and determine containment, correction, and prevention; execute action plans and determine the effectiveness of implementation• Aid in initial QMS training; train applicable employees on specific process and projects• Lead project team to a common goal; manage cross-functional team (including internal and client personnel)• Develop product requirements for non-implantable and implantable devices (including electronics and software); conduct and document design and development activities from project planning to regulatory submission (including FDA Class II 510(k), EU MDR Class IIa and IIb) • Design and generate working prototypes; develop V&V plans and protocols; execute testing and generate reports• Qualify suppliers/vendors based on component and device risk; communicate relevant requirements and non-conformances to suppliers; purchase and receive materials and components; track relevant raw, in process, and finished goods inventories• Relay necessary information to upper management and clients including project updates, complications, and schedule• Project experience includes: algorithmic temperature device (non-implantable), glaucoma shunt (implantable), peripheral nerve block catheter (non-implantable), esophageal catheter (non-implantable), tongue suspension (implantable), VR distraction goggle (non-implantable)

Broomfield, Co

Teach and guide students through reading, math, and study skills lessons; motivate students to succeed; track student progress; prepare students for the math and science sections of the SAT and ACT standardized tests; and provide homework help for math (primarily high school level), chemistry, and physics areas.

Set up applications for review, send out decision letters, help organize promotional events for prospective students, help track fees paid by prospective students, as well as other required tasks.

Chemical And Biochemical Engineering, Biochemical Engineering

Activities and Societies: Sigma Kappa Sorority, Up 'til Dawn, Society of Women Engineers, AIChEBS Chemical and Biochemical Engineering.

Education record