Megan Schlichting
Lino Lakes,MN
Overview
12
12
years of professional experience
Work History
Regulatory Affairs Manager
Medtronic – Cardiac Surgery
03.2022 - Current
- Manage 10 regulatory specialists and provide work direction to 5 contractors in order to resolve technical/operational problems and meet project schedules
- Assist in the development of global regulatory strategies to meet business objectives and maintain product compliance
- Reviewed technical documentation and submission for accuracy, ensuring alignment with regulatory expectations and industry standards
- Coordinated with clinical team on an IDE to support and submit applicable clinical data for an indication expansion original PMA
- Collaborate with the cross-functional organization to ensure global regulatory success
- Drive timely completion of regulatory support by managing workloads and priorities of the team
- Negotiate with regulatory authorities to resolve questions and issues that arise during the product lifecycle
- Provide targeted career coaching, develop team members at multiple levels and ensure clear personal and business performance objectives for each employee
- Kept abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape
Senior Regulatory Affairs Specialist
Medtronic - CRHF/CRM
12.2019 - 03.2022
- Acted as an Interim Regulatory Affairs Manager (November 2021 – January 2022) by providing guidance to regulatory specialists on key on-going projects and managing team priorities
- Supported initial EU MDR strategies, submitted for MDR product approvals, resolved deficiencies, obtained approvals, and mentored other RASs on EU MDR to drive consistency and quality across submissions
- Assessed product changes and completed appropriate regulatory deliverables and reports per applicable requirements
- Collaborated cross-functionally with R&D, reliability, and operations teams to align regulatory strategies with business objectives
- Fulfilled regulatory requirements for custom device requests and the development of new custom devices
- Maintained ownership of change control QMS series and overhauled the processes with a cross-functional team
- Provided change control training and continued coaching to change owners, quality, and other approvers
- Transitioned change control ownership within a cross-functional initiative to improve ease of work by providing guidance on combining procedures, implementing a risk-based approach and proposing tool updates
- Supported audit activities specific to regulatory requirements and change control
Regulatory Affairs Specialist
Medtronic - CRHF/CRM
07.2018 - 12.2019
Associate Regulatory Affairs Specialist
Medtronic - CRHF/CRM
06.2016 - 07.2018
Technical Aide
3M – Automotive Aftermarket
07.2013 - 06.2015
- Performed test method development and analytical testing of experimental adhesive formulations
- Responsible for sample preparation and maintaining accurate records in laboratory notebook spreadsheets
- Compiled, analyzed, interpreted, and documented results
Education
Bachelor of Science - Chemistry, Physics
University of St Thomas
St Paul, MN05.2016
Associate of Science - Chemistry
Inver Hills Community College
Inver Grove Heights, MN12.2013
Skills
- Regulatory Submissions and Strategy
- EU Medical Device Regulation (EU MDR)
- FDA 21 CFR 820
- FDA and Notified Body Interactions
- Change Control
- Product Lifecycle Management
- Procedure Pack Compliance
- Problem-Solving
- Technical Writing
- Leadership
Professional Awards
- Medtronic Global Regulatory Affairs Excellence Award Team Recipient (2018)
- Quarterly CRHF Quality Begins with Me Recognition (FY20Q3)
- Nominated for Medtronic Star of Excellence Award (2023)
Timeline
Regulatory Affairs Manager
Medtronic – Cardiac Surgery
03.2022 - Current
Senior Regulatory Affairs Specialist
Medtronic - CRHF/CRM
12.2019 - 03.2022
Regulatory Affairs Specialist
Medtronic - CRHF/CRM
07.2018 - 12.2019
Associate Regulatory Affairs Specialist
Medtronic - CRHF/CRM
06.2016 - 07.2018
Technical Aide
3M – Automotive Aftermarket
07.2013 - 06.2015
Bachelor of Science - Chemistry, Physics
University of St Thomas
Associate of Science - Chemistry
Inver Hills Community College