Philip Crompton Email & Phone Number

R&D Scientist-----------------With 9 years of industry experience as a R&D Scientist, I have participated in all aspects of a medical advice concern. A sampling of my capabilities are listed below: I have - - Organized and managed GLP animal studies.- Designed and Implemented successful yield improvement projects.- Successfully created and executed Test Protocols/Reports with the purpose of reinforcing claims concerning the product or its component parts.- Managed shelf-life testing protocols for critical process components- Designed and validated a new quantitative chemical assay method used across multiple sites. - Experience in use and method development for the following analytical instruments: GC, HPLC and UV-Vis Spectrometer.- Co-developed and implemented commercial solutions production processes.- Maintained continuing relationships with external vendors.In addition: I am able to act as a useful liaison between the laboratory and regulatory affairs department, ensuring the appropriate data is generated to satisfy the regulatory requirements of notified bodies and state regulatory agencies. My regulatory knowledge is further detailed in the section below.Regulatory Affairs-----------------In November 2016, I received a Certificate in Regulatory Affairs from the University of California, Santa Cruz - Silicon Valley Extension. The knowledge obtained through the certification process, combined with my 5+ years of experience in the medical device field, make me an attractive candidate for a Regulatory Affairs position. Below is a sampling of my knowledge regarding the expectations of regulatory agencies:- Quality management systems as detailed by ISO 13485:2016 and 21 CFR 820. - Risk management for medical devices as detailed by EN ISO 14971:2012 for the EU, and ISO 14971:2007 for the US.- The guidelines for risk management systems as outlined by ISO 31000:2009.- Pre-submission requirements by the FDA including Biocompatibility testing (ISO 10993:2009), shelf-life testing and design controls. - The submission requirements by the FDA, including: IDE (21 CFR 812), 510(k), De Novo 510(k) and PMA (PDP, HDE, Modular and Traditional). - Post-market surveillance requirements (21 CFR 822) for devices released in the US, including 522 order submissions, MDR (21 CFR 806) and complaint handling. - Labeling and Advertising requirements (21 CFR 801).

Listed skills include Microsoft Office, Research, Management, Microsoft Excel, and 23 others.

• 

  R&D Scientist

  Boston Scientific

  Feb 2012 - Oct 2020

  - Creating and troubleshooting test methods to characterize and quantify development materials- Analyzing and executing shelf life verification testing.- Conceiving and generating technical documents including test protocols and engineering reports.