Scott Saathoff
Overland Park,KS
Summary
Successful regulatory affairs professional with proven expertise in risk assessment and analysis, process improvement, and compliance. Skilled at working with internal teams and agency representatives to address issues head-on. Knowledgeable about regulatory trends, applicable guidelines, and industry impacts.
Overview
14
14
years of professional experience
Work History
Superintendent
Timber and Trowel - Home and Outdoor Design & Build
04.2025 - Current
- Oversee daily operations ensuring compliance with safety regulations and operational standards.
- Developed and implemented strategic initiatives that improved workflow efficiency across departments.
- Mentored and trained junior staff, enhancing team performance and fostering a collaborative work environment.
- Analyzed operational data to identify trends, facilitating informed decision-making for resource allocation.
Quality and Regulatory Affairs
Compass Minerals
07.2022 - 03.2025
- Lead liaison for FDA and CFIA (Canadian Food Inspection Agency) for Compass North American operations
- Lead for GFSI (Global Food Safety Initiative) 3rd party audit program (BRC Standard 9), and FSC 36 Safe Feed/Safe Food
- (Current grade for all food production facilities AA+)
- Lead for FDA/CBP (Customs and Border Protection) Prior Notice system for cross-border trade
- Lead regulatory consult for Organic, EPA Safer Choice, NSF certifications
- Lead for state tonnage and registration requirements
- Lead for Regulatory compliance for labeling of all product lines (food, feed, fertilizer, deicing salt, etc.)
- Consult for quality and regulatory documentation (content and distribution management)
- Consult for Salesforce Quality Service Incident system for quality incident resolution.
Mobile coffee shop
Scotty's Coffee Camper
07.2021 - 07.2022
- Purchasing, budgeting, billing, accounting, and marketing
- Product development and innovation utilizing flavors, ingredients, techniques
- Equipment acquisition, operation, and maintenance
- Licensure, tax, state registration management.
Self-Employed
Wabash Enterprises Home contracting services
09.2020 - 07.2022
- Home remodel services including design consulting, tile and other flooring, paint, landscaping, accent walls
- Purchasing, budgeting, billing, accounting, and marketing.
- Worked effectively in fast-paced environments.
- Self-motivated, with a strong sense of personal responsibility.
Technical Services Manager
Grandma Hoerner's Foods
01.2020 - 09.2020
- Management of all aspects of food safety, quality assurance, regulatory affairs, research & development, and sanitation for the food manufacturing facility
- Administer, develop, and maintain the FSSC 22000 certified Food Safety Management System to current standards
- HACCP and Preventive Controls administration and oversight
- Regulatory liaison to the FDA and KS Dept of Agriculture for compliance activities and duties
- Liaison with customers and suppliers regarding regulatory/specification compliance and quality assurance standards and monitoring
- Technical advisor on new product development, labeling compliance, quality specifications
- Direct supervision of the Quality Assurance team: Quality Assurance Manager, Quality Assurance Technicians (2), and Sanitation staff (2)
- Oversight and technical advisor to the Research & Development Manager.
Director of Manufacturing
Elias Animal Health
05.2018 - 01.2020
- Management and oversight of the manufacturing of proprietary cancer immunotherapy vaccine/t-cell treatment products
- Ensure adherence to internal Standard Operating Procedures (SOPs) and responsible for regulatory oversight management
- Logistics management for outbound/inbound shipments of patient samples and treatment products
- Manage and negotiate contracts with shipping vendors
- Created a comprehensive training program for evaluating the achievement of benchmark competencies for employees to be approved to manufacture outbound treatment products
- Liaison to CEO and CFO on short/mid/long-term manufacturing production projections, budgeting, personnel needs, facility and equipment upgrades, and process improvement
- Manage laboratory personnel work schedules including on-call/weekend/holiday manufacturing coverage.
Principal Investigator & Laboratory Manager
Ansera Analytics
09.2016 - 05.2018
- Oversee, manage, and direct all laboratory operations including oversight of all ongoing research, maintaining the library of bacterial cultures, and the supervision and direction of two employees and three interns
- Direct involvement in patent submission and oversight of the product development and validation of novel products for use in the food safety, biosecurity, and biodefense communities
- Promoted to Principal Investigator for CBRNE contract 10/2017
- Responsible for synthesizing data into monthly reports submitted to the U.S Department of Defense under CBRNE contract
- Content development and technical writing for abstract/journal article submissions/presentations.
Food, Drug, and Lodging Inspector II
KS Department of Agriculture
03.2012 - 09.2016
- Conduct food safety establishment audits in an assigned territory with responsibility for personal territory management to complete audit objectives within defined timelines
- Design and conduct food safety risk management training classes for regulated establishments to participate in with the goal of achieving long-term voluntary compliance with regulations and statutes
- Selected to conduct United States Department of Agriculture (USDA) Country of Origin Labeling (COOL) compliance inspections
- Promoted to Inspector II, March 2014
- Selected to the new hire training team to train new inspectors and to develop their risk management evaluation and inspections skills
- Selected as the department's subject matter specialist for Reduced Oxygen Packaging (ROP) and juice manufacturing Hazard Analysis and Critical Control Point (HACCP)
- Commissioned with the FDA to conduct food/beverage manufacturing audit inspections.
Education
Master of Public Health (MPH) - Food Safety and Biosecurity
Kansas State University
Manhattan, KS08.2011
Bachelor of Science - Kinesiology, Sports Medicine
Kansas State University
05.2001
Skills
- Regulatory audits
- FDA regulations, cGMP, FSMA, PCQI
- Technical writing and guidance
- Labeling requirements
- GFSI Standards
- Product recall management
- Cross-functional teamwork
- Food safety/quality assurance management
Timeline
Superintendent
Timber and Trowel - Home and Outdoor Design & Build
04.2025 - Current
Quality and Regulatory Affairs
Compass Minerals
07.2022 - 03.2025
Mobile coffee shop
Scotty's Coffee Camper
07.2021 - 07.2022
Self-Employed
Wabash Enterprises Home contracting services
09.2020 - 07.2022
Technical Services Manager
Grandma Hoerner's Foods
01.2020 - 09.2020
Director of Manufacturing
Elias Animal Health
05.2018 - 01.2020
Principal Investigator & Laboratory Manager
Ansera Analytics
09.2016 - 05.2018
Food, Drug, and Lodging Inspector II
KS Department of Agriculture
03.2012 - 09.2016
Bachelor of Science - Kinesiology, Sports Medicine
Kansas State University
Master of Public Health (MPH) - Food Safety and Biosecurity
Kansas State University
Awards
American Society for Microbiology (ASM) “2018 Biothreats: Research, Response, and Policy meeting.” Abstract poster presentation: “Optimized Biological Sample Transport.” February, 2018. Awarded Travel Grant for quality of scientific work, American Society for Microbiology (ASM) “2017 Biothreats: Research, Response, and Policy meeting.” Abstract poster presentation: “Optimized Biological Sample Collection.” February, 2017, Preventive Controls Qualified Individual (PCQI). 2016, FDA Office of Regulatory Affairs (ORA) Honor Award for Outstanding Service. 2015, FDA ORA Honor Award for Listeria monocytogenes response. 2014, FDA Commissioned Inspector, 2014, FDA Training: FD 180 - Food Good Manufacturing Practice, Application, and Evidence Development. February 4-12, 2014, FDA Training: FD 152 - Food Core III Food Processing and Technology. May 5-9, 2014, FDA Training: Environmental Sampling. June 13, 2013, FDA Training: FD 218 - Risk Based Inspections, January 28-29, 2013, KDA Training: Food Manufacturing Training program and Lodging Training program. 2013-14, National Environmental Health Association: Environmental Health Training in Emergency Response (EHTER), Sept. 2012
KEY QUALIFICATIONS
- PCQI certified
- HACCP certified
- Food Safety Regulation-retail and food manufacturing, state and federal
- Analytic instrumentation expertise
- Food Safety Training
- Regulatory Science
- Lab instruction and training
- Retail food establishment ownership/operation
- Analytical thinking
- Creative problem solver
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