Herman Smith

Owned and led best practices for label and IFU design, implementation, and process optimization across multiple product lines. Interpreted and applied global labeling regulations, mentoring team members on evolving standards and regulatory expectations. Drove strategic labeling initiatives, including harmonization projects and digital eIFU integration, while managing controlled label releases usin

Ensured regulatory compliance by conducting thorough audits and assessments of company policies and procedures. Improved operational efficiency through consistent monitoring, analyzing, and improving the organization’s compliance programs. Collaborated with cross-functional teams to develop comprehensive risk management strategies and assisted in the preparation of regulatory submissions.

Led the development, revision, and approval of device labeling and IFUs for Class II and III surgical instruments in compliance with FDA, EU MDR, and country-specific requirements. Enhanced visually appealing designs for packaging using Adobe Creative Cloud and managed change controls and document approvals through Agile PLM system. Implemented Unique Device Identification (UDI) labeling per GS1 s

Collaborated with Marketing, Regulatory, Quality, and Legal stakeholders in preparing and maintaining compliant labeling per ISO 13485 and MDD/MDR requirements. Provided guidance on label content per ISO 15223-1:2021 and drafted labeling for 510k submissions. Led cross-functional coordination for the successful migration of 300+ SKUs to the Prisym PLM system following a corporate merger.

Reviewed artwork to ensure label claims were compliant with the drug monograph and responded to health authorities inquiries per labeling submissions (eCTD). Streamlined regulatory processes for increased efficiency in submitting drug applications to the FDA and Health Canada. Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.

Reviewed and approved labels created by vendors, ensuring completeness and regulatory alignment, and acted as Labeling Process Owner. Updated labeling databases and tracked artwork changes across multiple SKUs. Collaborated with Quality Assurance, Regulatory, and Marketing to create global packs for IOLs devices for the EU, directing translation procurement and verifying accuracy.

Operated calipers and barcode verification scanners for performing labeling test reports, and created RX and OTC labeling designs. Communicated with external print vendors and inspected printed components from suppliers. Ensured accuracy of revision codes to all commercial and OTC printed components by proofing against master reference files.

Obtained an Associate of Applied Science in Telecommunications. Gained foundational knowledge and practical skills in telecommunications systems, network operations, and related technologies.

Completed a Bachelor of Arts degree with a focus on Graphics Design. Developed skills in visual communication, digital design tools, and creative problem-solving.