Louwanna Wilson
Ft Wayne,Indiana
Summary
Regulatory professional skilled in managing complex projects and ensuring compliance with industry standards. Known for strong focus on team collaboration and achieving results, adaptable to changing needs. Expertise in regulatory documentation, risk assessment, and stakeholder communication. Reliable and effective under pressure, with track record of delivering successful outcomes in dynamic environments.
Overview
12
12
years of professional experience
Work History
Principal Regulatory Affairs Consultant
Quality Regulatory Solutions, LLC
01.2022 - Current
- Developed global project strategies for international registrations including meetings with CDRH, CBER, CDER, BSI, and other notified bodies
- Regulatory lead for global new product development of 23 product families submitted as IDE, De Novo, BLA supplements, and 510(k) with consideration of clinical studies, software, robotics, and pharmaceuticals
- Managed the implementation of the MDR regulation in 112 global markets outside the US and EU for 17 Technical Documents and Design Dossiers for class II and III medical devices
- Monitored changes in regulations and communicated impacts to stakeholders effectively.
- Led teams with a focus on mentoring to ensure regulatory success
- Established strong relationships with key stakeholders at regulatory agencies, fostering open communication channels for prompt issue resolution.
- Advised clients on best practices for navigating complex regulatory environments efficiently.
- Optimized internal processes through continuous improvement initiatives, resulting in increased efficiency and cost savings across the organization.
- Served as a subject matter expert during meetings with clients and partners, confidently representing the company''s regulatory expertise.
Senior Specialist, Regulatory Affairs
Boston Scientific
11.2020 - 01.2022
- Communicated with global and regional/local regulatory agencies
- Researched, developed, and implemented regulatory strategies for modified medical devices
- Assessed the acceptability of quality, preclinical and clinical documentation for submission filing
- Prepared regulatory submissions for US (Class I and II) and EU (Class I, Is, IIa; and IIb) according to EU MDR
- Provided regulatory approval for marketing collateral: training materials, product brochures, and other materials, written and video
- Coordinated project timelines and resources to ensure on-time completion of key initiatives.
- Represented Regulatory Affairs on development core teams, providing Regulatory guidance throughout the product development cycle
- Reviewed and approved device labeling and advertising materials for compliance with applicable global regulations
- Analyzed data trends to inform strategic decision-making and improve service delivery.
- Collaborated with stakeholders to align project goals with organizational objectives and customer needs.
Senior Specialist, Regulatory Affairs
Viant Medical
04.2019 - 10.2020
- Monitored the global regulatory environment and provided assessments of the impact of new and changing regulations on the company's research and development programs to management
- Monitored impact of changing regulations on submission strategies, including OUS registration strategies and requirements
- Authored 8 Technical Documents to remediate ISO compliance
- Created template for GSPR and Technical Documentation for EU MDR
- Provide regulatory guidance on cross-functional teams in support of a legal name change project which included registration updates for Canada, MDSS, and the EU
- Regulatory lead for cross functional EU MDR compliance project
- Authored Clinical Evaluation Report procedure based on the EU MDR
- Determined and communicated submission and approval requirements to other team members
- Mentored junior specialists, fostering skill development and promoting a collaborative work environment.
Regulatory Affairs and Quality Assurance Specialist
ConMed Corporation
03.2017 - 03.2019
- Exercised highly complex level of independent judgment and execution directly impacting the operational results of the business unit across multiple critical projects
- Defined the strategic regulatory direction for pipeline development and global launch
- Partnered with R&D and Global Strategic Marketing leaders to develop and implement strategy for pipeline development and global launch excellence for EU Class II devices
- Provided regulatory guidance on cross-functional teams to develop and implement regulatory strategies for new products, including original equipment and virtual manufacturing relationships
- Communicate to regulatory agencies and notified bodies as part of the submission and approval processes for medical devices: MDSS, Health Canada, FDA, and BSI
- Review engineering change requests, labeling, packaging, and manufacturing changes to global submissions throughout the life cycle of the product
- Review and approve proposed labeling: IFUs, and package labels
- Responsible for tracking and assuring continued compliance with external standards
- Regulatory product lead for CAPA investigations and Nonconformance resolution
- Member of the Complaint Review Board
- Established and ensured deployment of learning initiatives and training of cross functional partners on current and emerging regulatory and related requirements
- Assured timely regulatory clearances for key product launches in all key markets and implemented a strategic vision with tactical plans consistent with the organizational and RA strategic objectives
- Assessed the acceptability of quality, preclinical and clinical documentation for submission filing
- Led regulatory submissions, ensuring compliance with FDA and international standards.
- Developed and implemented strategies for product approvals, reducing time to market.
- Reviewed labeling and promotional materials for compliance with regulations.
Regulatory Affairs Specialist
Zimmer Biomet
12.2013 - 03.2017
- Managed regulatory affairs as part of a cross-functional team for a remediation project involved in assessing design documentation for compliance to Quality System Regulation (FDA 21 CFR 820)
- Led a regulatory team of 5 responsible for regulatory impact assessment, analysis processes, regulatory compliance, and ensuring that deliverables were completed on time
- Created best practices for remediation while driving cross-segment regulatory alignment
- Conducted 222 audits and provided guidance on design change documentation, risk management files, design history files, and design inputs, outputs, verification and validation
Education
Master of Science - Orthopedic Regulatory and Clinical Affairs
Grace College
Winona Lake01.2013
BS - Business Administration and Management
Grace College
Winona Lake, IN05-2012
Skills
- Global Regulatory Submissions
- International Regulatory Compliance
- SaMD
- Agency Communication (FDA, BSI GMED)
- EU MDR
- 510(k) / E-STAR
- Medical device regulations
- De Novo
- IVD
- Windchill
- RIM
- ETQ Reliance
- VEEVA
Professional Courses
Regulatory Affairs Training Program, Pharma, Duke University School of Medicine, 2022
CC Certified in Cybersecurity Certification, ISC-2, 2024
Timeline
Principal Regulatory Affairs Consultant
Quality Regulatory Solutions, LLC
01.2022 - Current
Senior Specialist, Regulatory Affairs
Boston Scientific
11.2020 - 01.2022
Senior Specialist, Regulatory Affairs
Viant Medical
04.2019 - 10.2020
Regulatory Affairs and Quality Assurance Specialist
ConMed Corporation
03.2017 - 03.2019
Regulatory Affairs Specialist
Zimmer Biomet
12.2013 - 03.2017
Master of Science - Orthopedic Regulatory and Clinical Affairs
Grace College
BS - Business Administration and Management
Grace College