Brandi Schmidt
Saint Charles,MO
Summary
Seasoned regulatory affairs officer with 18 years of experience in developing effective processes and executing regulatory affairs initiatives for the medical device and pharmaceuticals industry. Successfully improved processes and assisted in product development to ensure compliance with regulatory requirements. Meticulously maintained and followed up on records of regulatory information and submissions. Possess a comprehensive understanding of current US, Canada, EU, and UK regulations, standards, and best practices. Highly analytical and detail-oriented professional dedicated to ensuring that products meet all relevant domestic and international regulatory requirements. Known for being methodical, objective, and possessing excellent judgment, critical thinking, and problem-solving abilities.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Manager Regulatory Affairs
Bausch & Lomb
05.2024 - Current
- Managed all aspects of regulatory development for medical systems
- Collaborates with cross-functional teams to navigate regulatory requirements, strategizes regulatory approach based on current guidelines and effectively communicates with Regulatory Authorities regarding assigned products
- Engaged in ongoing communication with regulatory counterparts to ensure integration of regional requirements into product strategy development.
- Developed a product regulatory timeline that aligned with the company's product development. This included key regulatory milestones and activities for agency filings including 510K, MDD, MDR, Canada, and ROW.
- Contributed to the development of labeling content and product documentation in accordance with regulatory standards.
- Collaborated with product development teams to ensure understanding of Regulatory Authority regulations and deadlines for submissions
- Liaised with essential collaborators and regional equivalents, guaranteeing the on-time and precise submission of materials to Regulatory Authorities.
- Took on the role of regulatory contact for devices and software
- Coordinated interdepartmental efforts for successful completion of Regulatory Authority inspections.
- Provided regulatory guidance/input to device change control and internal product review boards
- Managed a team of employees.
- Accomplished multiple tasks within established timeframes.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.
- Streamlined workflows by identifying bottlenecks in existing systems and implementing appropriate solutions.
Senior Regulatory Affairs Associate
Bausch & Lomb
01.2021 - 05.2024
- Project Subject Matter Expert (SME) in Medical Device 510K, MDD/MDR Class IIa, IIb, III
- Labeling MDR project manager in Medical Device finished product and IFU, including MDR, UKCA, Saudi, and Swiss
- Including CE marking, CE removal, and consolidation of SKU’s with notified body (BSI & TUV)
- Author of MDD to MDR transition of Medical Device Class IIa/IIb/III (currently authoring 6 large MDR tech files)
- Author US 510K (eStar), PMA, EU MDR, Canada, and multiple global filings
- Coordinate submissions of product development and commercialization, that they are complete, accurate, and submitted promptly while abiding by regulations, guidelines, and standards
- Implemented Global post-approval review of manufacturing changes, including SOP’s/WI’s/System Improvements
- Evaluate all post-approval activities for global impact on new and existing filings and provide strategic regulatory guidance for optimal implementation of changes
- Support R&D and validation activities, marketing applications, and global audits in conformance with regulatory requirements, strategies, and commitments
- Maintain and archived project status, including regulatory paperwork (RIMS, Veeva, RegDesk) -ICH compliance, Site Standards compliance, SOP/WI creation and maintenance
- Effectively communicate timelines and key performance indicators by collaborating with R&D, QA, QC, and engineering.
- Expert in time management to achieve milestones and provide contingency plans if needed per status updates from key team members.
Associate Manager of Regulatory Affairs
Virbac Animal Health
03.2015 - 08.2020
- Enforced high standards of preparing and submitting necessary Veterinary pharmaceutical post-approval (CMC) supplements and reports reviewing and compiling gap assessment documents for submission to FDA/CVM
- Provided technical support, advice, and strategic insights to other teams within Virbac, actively taking part in industry associations and showing proficiency in various systems and guidance
- Demonstrated commitment to Veterinary regulatory compliance by setting and enforcing high standards of performance and service, resulting in consistent, high-quality environment for the organization
- Successfully authored and maintained all CMC post-approval compliance for NADA, ANADA, and DMFs, and efficiently prepared and submitted necessary supplements and reports within required regulatory deadlines
- Reduced regulatory review time by 92%
- Implemented new Global CMC Post-Approval effective system
- Actively took part in industry associations and provided valuable technical support, advice, and strategic insights to other teams within Virbac, demonstrating a deep understanding of the regulatory landscape and contributing to the overall success of the organization.
Senior Regulatory Affairs Specialist
Mallinckrodt Pharmaceuticals
01.2011 - 01.2015
- Led product teams in overseeing small molecule regulatory compliance on CMC Global change management, evaluating plans and recommendations for process improvements, ensuring successful implementation of regulatory changes and compliance with regulations
- Managed CMC post-approval regulatory aspects for Drug Substance manufacturing, covering PAS, CBE-30, CBE-0, and annual reports.
- Authored and implemented regulatory strategies for Global CMC impact, resulting in successful approvals and compliance with regulations
- Prepared and managed dossiers, ensuring compliance with regulatory requirements for investigational and marketed products, resulting in successful product marketing authorizations
- Leveraged eCTD and assisted in maintaining regulatory standards and implementing new systems for tracking Letters of Authorizations, clinical trial applications, and marketing authorizations.
- Provided expert guidance to product development teams, facilitating the integration of regulatory considerations into design and manufacturing processes.
- Assisted in the due diligence process for potential business acquisitions, assessing regulatory risks and providing valuable input on integration strategies.
Quality Engineer
Mallinckrodt Pharmaceuticals
01.2005 - 01.2011
- Promoted to Quality Engineer from Buyer I/II, responsible for authoring and coordinating product review documents following FDA, EPA, DEA, Q7A, and Sector Guidelines.
- Provided support to quality team members updating corrective actions, conducting inspections, and contributing to root cause analysis for product qualities
- Authored and managed annual product review projects, ensuring compliance with FDA, EPA, DEA, Q7A, and Sector Guidelines to pass regulatory audits and maintain high-quality standards of safe and effective products for consumers
- Collaborated with manufacturing team members to address and resolve quality issues during the project's corrective action updates, driving increased production and cost savings for the company.
- Managed Quality Systems, ensuring compliance with ISO and other regulatory requirements as a quality manufacturer
- Instructed and tracked Change Management compliance for the manufacturing site.
- I developed inspection plans based on design specifications, ensuring that we verified all critical dimensions and performance criteria throughout the manufacturing process.
- Improved customer satisfaction levels with a timely resolution of non-conformance issues and effective corrective actions.
- Conducted detailed audits to ensure adherence to ISO 9001 standards, maintaining a high level of compliance throughout the organization.
Education
Doctorate (DPP) - Regulatory And Clinical Research
Arizona State University
Tempe, AZ12.2027
MBA - Business Administration And Management
DeVry University
St Louis, MO01.2023
Bachelor of Science - Biomedical Engineering
Washington University (St. Louis)
St Louis, MO05.2005
Skills
- Thought Leadership
- Global Regulatory
- Project Management
- Regulatory Compliance and Strategy
- Change Leadership
- Group Collaboration
- Communication
- US Standards, Regulations & Policies
- Business Development
- Pharmaceutical and Medical Device Regulations
- CGMP, ISO, EU MDR 2017/745, UKCA, UDI, US, Canada, LATAM, China, Japan and ROW regulatory
- Labeling Compliance
- GxP Knowledge
Affiliations
- Active Member of RAPS
Certification
- Six Sigma Green Belt (2008)
- Project Management Professional (PMP) (exp 2024)
Timeline
Manager Regulatory Affairs
Bausch & Lomb
05.2024 - Current
Senior Regulatory Affairs Associate
Bausch & Lomb
01.2021 - 05.2024
Associate Manager of Regulatory Affairs
Virbac Animal Health
03.2015 - 08.2020
Senior Regulatory Affairs Specialist
Mallinckrodt Pharmaceuticals
01.2011 - 01.2015
Quality Engineer
Mallinckrodt Pharmaceuticals
01.2005 - 01.2011
Doctorate (DPP) - Regulatory And Clinical Research
Arizona State University
MBA - Business Administration And Management
DeVry University
Bachelor of Science - Biomedical Engineering
Washington University (St. Louis)
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