Hillary Peetsch
Regulatory Affairs Specialist
Minneapolis,MN
Summary
Regulatory Specialist Highly collaborative diligent professional with eight years’ experience in regulatory industry. Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with data analysis, report writing and recordkeeping abilities. Collaborated with internal and external teams to develop transparent and compliant regulatory processes.
Overview
8
8
years of professional experience
6
6
years of post-secondary education
Work History
Regulatory Affairs Specialist
Medtronic Inc
Mounds View, MN
03.2020 - Current
- Function as an interface between FDA and engineering, design, and manufacturing teams for changes that require documentation and/or prior approvals before implementing
- Prepare and submitted FDA and EU submissions for post-market changes (Annual Reports, 30-day notices, 180 day, RTR submissions, Annual Performance Reports)
- Support procedure innovation team to ensure that procedures meet country specific regulatory requirements, quality management system requirements, and ISO requirements
- Prepare and submit EU MDR technical files for EU MDR Remediation products.
- Prioritize project-related tasks to efficiently complete essential tasks.
- Work with geography partners to assess post-market changes and determine submission deliverables.
- Support the custom devices team by reviewing doctor requests and coordinating geography deliverables.
Regulatory Specialist
H.B. Fuller Company
St. Paul, MN
03.2015 - 04.2020
- Work with technical, R&D, and business units to ensure compliance with local and global chemical laws for new and existing products
- Collect and prepare chemical and technical information to submit new chemical submissions (PMNs) to the EPA
- Support global colleagues in their regional and country specific chemical submissions
- Review and approve labeling under GHS and CSPC labeling schemes
- Manage EPA FIFRA Registrations (Pesticide registrations)
- Provide import/export paperwork for domestic customs and international shipments
- Provide customer support on determining product compliance to LEED certification or other green building compliance schemes.
Regulatory Specialist
Pace Analytical - Contracted By 3M
St. Paul, MN
11.2013 - 03.2015
- Supported the Automotive Aftermarket Regulatory Affairs department by maintaining supplier chemical records.
- Collected regulatory information from 3M chemical suppliers.
- Maintained product formulas and raw material information in ERP system (SAP).
- Assisted product responsibility liaison (PRLs) with preparing regulatory reporting documentation.
- Author and reviewed GHS SDSs.
Education
Bachelor of Science - Biology Business Administration
University of Minnesota
09.2009 - 05.2013
Master of Science - Regulatory Affairs Science
University of Saint Thomas
01.2020 - 05.2022
Skills
Project Management
Global Regulatory Compliance
Prioritization
Timeline
Regulatory Affairs Specialist
Medtronic Inc
03.2020 - Current
Master of Science - Regulatory Affairs Science
University of Saint Thomas
01.2020 - 05.2022
Regulatory Specialist
H.B. Fuller Company
03.2015 - 04.2020
Regulatory Specialist
Pace Analytical - Contracted By 3M
11.2013 - 03.2015
Bachelor of Science - Biology Business Administration
University of Minnesota
09.2009 - 05.2013