1. PAUL E SCHAFER
1705 Montilla Street Santee, CA, 92071 (619)-519-4528 schafedog@gmail.com
Regulatory Affairs Specialist with 5+ years of experience working in an ISO 13485 medical diagnostic device
manufacturing facility. Possesses experience in post-marketing regulatory processes and an expertise in Microsoft
Excel. Looking to leverage my knowledge and experience into a role as a Regulatory Affairs Specialist.
PROFESSIONAL EXPERIENCE
ACCUMETRICS, INC. /ACCRIVA DIAGNOSTICS, San Diego, CA
Regulatory Affairs Specialist I, April 2014 – Present
 Coordinated with international distributors and sales staff to facilitate registration of Accriva’s medical devices
 Managed all Level 1 and Level 5 complaints information to assist with MDR decision and coordinate potential
follow-up MDRs
 Conducted final review of all Level 1 and Level 5 complaints, for documentation content accuracy, prior to closure
 Performed reconciliatory actions for all company recall, corrections and removals
 Facilitated Regulatory Affairs support to Customer Support inquiries
Quality Specialist I, January 2012 – April 2014
 Performed document review for all reagent, device and instrument DHRs prior to product release
 Managed compliance to training requirements for all employees
 Reviewed for closure all non-significant customer inquiries
 Performed duties of Document Control as replacement to absentee staff members
Quality Assurance Assistant, July 2010 – January 2012
 Support Quality Department with scanning and filing of critical quality documents, including DHRs and validations
 Performed preliminary DHR document review
 Assisted with notification and recording of required quality training
SEMPRA GLOBAL, San Diego, CA
Records Analyst, July 2007 – July 2009
 Coordinated development of taxonomy structure for individual Business Units and assisted with implementation into
the existing Documentum structure.
 Participated in metadata standards content review and implementation.
 Created and conducted pre-release performance testing of Retention Policy Services software.
 Performed physical document audits and established retention code assignments to reviewed documents.
 Created and managed the departmental SharePoint site
MEMBERSHIPS
 San Diego Regulatory Affairs Network
ADDITIONAL SKILLS
 Expert in Microsoft Office, with a focus on Excel
 Web and tech savvy, require little to no training
 Experience with report generating from Oracle JD Edwards Enterprise One
 Completed the RAPS training for Medical Devices