Scott Buchheit is seeking a regulatory specialist position in the Minneapolis-St. Paul area. He has extensive experience in medical device regulatory affairs and FDA regulated environments, including authoring technical file documents for Europe and ensuring compliance of product literature. Buchheit has a Master's in Regulatory Affairs and Services from St. Cloud State University expected in December 2015, as well as certifications in quality management. He aims to apply his regulatory strategies and submissions experience, including for 510(k)s, PMAs, and IDEs, to a new position.

1. Scott A. Buchheit
5905 36th Ave N CrystalMN 55422
763-592-9919 scottbuchheit@ymail.com
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Regulatory Affairs and Services professional with extensive training and
experience in Medical Device Regulatory Affairs and Services, Pharmaceutical
Manufacturing, and FDA regulated Environments seeks Regulatory Specialist
Position in Minneapolis-St Paul Area
KEY COMPETENCIES
 Regulatory Strategies
 PMA Supplements
 510(k), PMA, IDE submissions
 MDR Vigilance
 Class I, II, and III devices
 Labeling Verification
 Quality Systems Management
 Declarations of Conformity
 CE Marking
 GMP, SOP, V&V, Inspection
 Process Documentation
 CAPA/Process
Review/improvement
PROFESSIONAL EXPERIENCE
MS REGULATORY AFFAIRS CULMINATING PROJECT
Twin Star Medical Minneapolis, MN Jun 2015 - Oct 2015
Project involved preparation and submission of meeting request and briefing package
documentation for PIND meeting with the FDA
REGULATORY AFFAIRS GRADUATE STUDENT
St Cloud State University Maple Grove, MN Sep 2012- Dec 2015
 Relevant Coursework for MS Regulatory Affairs completed:
RAS 635 Regulatory Affairs Compliance
RAS 651 Regulation of Combination Products
RAS 625 Regulatory Routes to Market: PMA
RAS 655 International Regulatory Affairs: Japan
RAS 627 Intl Regulatory Affairs: Europe
RAS 623 Regulatory Routes to Market: 510(k)
RAS 631 IDE Regulations and Clinical Trial Design
RAS 621 Legal Basis for Medical Device Rules and Regulations
RAS-633 Quality Systems for Regulated Industry/ Medical
Technology
RAS-643 Reimbursement and Cost Management
Graduation expected December 2015
REGULATORY AFFAIRS SPECIALIST
SMITHS MEDICAL ASD, INC. St. Paul, MN Sep 2014 – Jan 2015
 Author of STED Technical File Documents for Europe for a variety of Smiths
Medical products
 Performed Declaration of Conformity updates for Smiths Medical HQ products
 Identified gaps in submission documents and initiated steps to correct and
update

2. Scott Buchheit
763-592-9919 Page 2
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 Reviewed product literature to ensure compliance with FDA and international
submissions on file
 Reviewed technical literature (labeling, IFU's, manuals, patient guides, etc.),
sales and marketing literature, related to company products to ensure
compliance with applicable standards and regulations
WEIGH BLEND COATING TECHNICIAN
Cima Labs Eden Prairie, MN Dec 2003 – Sep 2012
 Was put in charge of 1 CAPA project and was member of team charged with
conducting and executing 5 other CAPA projects.
 Participated in the manufacturing of pharmaceutical products. Expertise in
weighing, blending and coating.
 Saved company over $250,000 applying Lean Six Sigma Techniques by
improving coating process equipment
 Accurately performed Validation of processes and equipment to ensure FDA
compliance and ISO requirements.
 Performed Verification of processes to ensure final products met specifications.
 Integral and active member of Process Improvement team whose efforts created
operations efficiencies and cost savings to the company
 Provided training and mentoring to new operators to ensure a smooth on
boarding experience.
EDUCATION AND OTHER
 Masters of Science, Regulatory Affairs & Services
St. Cloud State University, St. Cloud, MN Sept 2012 - Dec 2014
Expected Completion Fall 2015 (Pending Culminating Project completion,
classroom work completed June 2014)
 Bachelor of Science-Physics
University of Minnesota- Duluth 1987
 Certifications
ASQ-Certified Manager of Quality/ Organizational Excellence
ASQ-Certified Quality Auditor
ASQ-Certified Quality Improvement Associate
AFFILIATIONS
 President of RACEline, the student organization for regulatory, clinical and
quality leaders at St Cloud State University 2013-2014, Vice–President 2012-
2013
 Member of American Society for Quality (ASQ)
 Program committee member for MN ASQ.
 Eagle Scout- Boy Scouts of America
 Scoutmaster Troop 289 in Crystal MN for 3 years