9650 Milliken Avenue
Rancho Cucamonga, CA 91730
I am in the process of making a career change. As referenced generally in my resume, Keck Graduate Institute emphasizes the life sciences with various sub-specializations. I have significant science, legal, medical, and accounting backgrounds as well as course work in Regulatory & Clinical Affairs, Validation, and several courses in the business of bioscience. My work relating to the Internal Revenue Service exposed me to many sophisticated filings in conjunction with related regulations, interpretations, and applications of polices and guidance. Further, my work in medical malpractice had me observing hundreds of surgeries and medical procedures and allowed me to shadow surgeons, physician assistants and nurses for hundreds of hours. The classes in the business of bioscience exposed me to the American and International patent regimes. My daily work for several large pension funds involved creating partnerships, investing in conjunction with venture capitalists and start-up companies and negotiating financing.
I am a licensed Pharmacy Technician.
Please refer to LinkedIn for more information which includes links to some of my work:
As referenced above, I have worked with ISO 13485 and 21 CFR 820 (Quality Systems Regulations). I have experience with inspections, audits (I started out in a Big 8 accounting firm) and academic experience with risk and root cause analysis as well as Design History Files/Device Master records.
I have majored in Regulatory & Clinical Affairs and studied Validation. My study and experience in validation is broad-based. My most intensive experience is in analytical validation/product development and ISO 15197:2013(E). However, I also have exposure to other types of Validation. I have worked with ISO 13485 and 21 CFR 820 (Quality System Regulations). Please see my resume regarding my experience – including my legal experience – i and study of Clinical & Regulatory Affairs in conjunction with my background.
One project with which I was engaged had to do with a patent application, marketing and licensing of an invention at a local university (agricultural technology).
Please note that my compensation expectations are modest and I am willing to travel. If my employment is largely located in the western metropolitan region of Los Angeles, San Diego or San Francisco. I intend to move there from my current residence in Rancho Cucamonga.
I would urge you to contact Dr. Susan Bain, Professor and Program Director, Clinical, Regulatory and Quality Affairs at 909.607.9859 and/or firstname.lastname@example.org .
Recognizing that this brief summary cannot provide all of the information needed to describe my skills, experience, and accomplishments, I welcome the opportunity to speak with you in person.
Thank you for your time and consideration.