Jasmine Ralston
Summary
Regulatory Affairs professional with extensive experience in regulatory review, quality assurance, and business analysis. Demonstrated success in managing complex projects and ensuring timely compliance with global standards, leading to the approval of innovative medical products. Skilled in data analysis and effective communication, fostering collaboration with cross-functional teams and regulatory agencies. Proven ability to navigate intricate regulatory environments within the life sciences and healthcare sectors, enhancing workflow efficiency and maintaining product integrity.
Overview
17
17
years of professional experience
Work History
Volunteer Judge Advocate
Disabled American Veterans Auxiliary
Rochester, MN
04.2023 - Current
- Offered guidance on regulation and compliance issues.
- Researched and analyzed laws and statutes to assist in making just decisions.
- Ensured adherence to regulatory standards during audits.
- Directed maintenance and administrative functions of the local veteran cemetery.
- Allocated upwards of 150 hours.
Senior Regulatory Affairs Specialist
Benchmark Electronic
04.2021 - Current
- Administer regulatory functions and workflows for medical devices and consumer products during all phases from initial creation to post-market.
- Created and implemented multifaceted regulatory strategies for global markets.
- Managed submissions for US FDA approval, including pre-sub and 510(k) applications.
- Draft EU Technical Files and Declaration of Conformity documents, maintaining adherence to global regulations.
- Expert in US (FDA), EU (MDD), and Canada (Health Canada) regulatory requirements.
Regulatory Affairs Specialist II
Medtronic
08.2012 - 02.2017
- Drafted and organized compliance documents for novel products, facilitating punctual product launch.
- Integrated worldwide compliance guidelines into project strategies.
- Prepared documentation for regulatory compliance.
- Collaborated in project meetings to devise plans ensuring adherence to regulatory standards.
- Performed periodic reviews of existing products to ensure ongoing compliance with applicable laws and regulations.
Distribution Management Specialist
United States Marine Corps
09.2007 - 04.2012
- Analyzed company's expenditures and developed financial models.
- Evaluated employee performance against established goals, providing coaching as needed.
- Evaluated needs of departments and delegated tasks to optimize overall production.
- Implemented strategies to take advantage of new opportunities.
- Facilitated meetings between various departments to discuss project progress and brainstorm new ideas.
- Identified needs of customers promptly and efficiently.
- Created plans to propose solutions to problems related to efficiency, costs or profits.
Education
Master of Science - Research Biology
Northeastern University
01.2025
Regulatory Affairs Certificate -
Northeastern University
01.2023
Master of Science - Business Administration
Webster University
01.2020
Bachelor of Science - Business Administration
Hawaii Pacific University
01.2011
Volunteer Experience
Judge Advocate, Disabled American Veterans, 04/23, Present, Regulation/legal advice, Audits, Managed local veteran cemetery., Dedicated over 150 hours.
Timeline
Volunteer Judge Advocate
Disabled American Veterans Auxiliary
04.2023 - Current
Senior Regulatory Affairs Specialist
Benchmark Electronic
04.2021 - Current
Regulatory Affairs Specialist II
Medtronic
08.2012 - 02.2017
Distribution Management Specialist
United States Marine Corps
09.2007 - 04.2012
Master of Science - Research Biology
Northeastern University
Regulatory Affairs Certificate -
Northeastern University
Master of Science - Business Administration
Webster University
Bachelor of Science - Business Administration
Hawaii Pacific University
Similar Profiles
Jeff LuchtJeff Lucht
National Service Officer /Outreach Specialist at Disabled American Veterans/ Veterans AdministrationNational Service Officer /Outreach Specialist at Disabled American Veterans/ Veterans Administration
Gabriella SierrasGabriella Sierras
Volunteer Clerical Assistant at Disabled American Veterans AuxillaryVolunteer Clerical Assistant at Disabled American Veterans Auxillary
James GravesJames Graves
Head Service Coordinator at Disabled American Veterans Department Of New YorkHead Service Coordinator at Disabled American Veterans Department Of New York
Daniel BagleyDaniel Bagley
Deputy Staff Judge Advocate/ M.J Chief, TF Spartan at United States ArmyDeputy Staff Judge Advocate/ M.J Chief, TF Spartan at United States Army
Fernando CortesFernando Cortes
Staff Judge Advocate paralegal at United States Marine CorpsStaff Judge Advocate paralegal at United States Marine Corps