Jennifer Bolton

• Lead global regulatory strategy and execution for two medical device platforms undergoing multi-phase redesign over a 5-year roadmap. Own all regulatory deliverables for New Product Development (NPD), change control, and clinical support across US and EU markets.
• · Manage global regulatory timelines and deliverables for NPD initiatives and design changes across both product lines.
• · Conduct regulatory impact assessments under US FDA and EU MDR, including significant change evaluations and STED updates.
• · Author and submit 510(k) applications for new device configurations; manage eSTAR template and FDA communications
• · Submit Significant Change Determinations to Notified Body under EU MDR.
• · Serve as regulatory lead on two ongoing clinical trials; provide feedback on protocols and indication for use strategies.
• · Partner with cross-functional teams to define De Novo submission strategy and shape regulatory pathways for expanded indications.
• · Advised executive team on global rollout sequencing to align regulatory strategy with commercial priorities.

Initially responsible for peripheral IV catheter products for companywide project Recode. Transitioned to platform RA representative supporting change control projects for a portfolio of products worth over 1 billion dollars in annual revenue.

· As Regulatory Project Manager for CEO Award winning project Recode, provided strategic input and regulatory guidance for worldwide implementation of new products globally while discontinuing older product offerings. Coordinated efforts by cross functional team to register products in Greater Asia, Middle East, Europe, Eastern Europe, and South America. Managed 90 registration timelines for 2021 to ensure approvals would be obtained before discontinuation of previous product. An additional 140 registrations were completed in 2022. Created the planned submission timelines globally for products under development.

· Supported change control projects by assessing US and EU regulatory impact, UDI impact, need for STED updates, and managing international impact to project timeline and implementation strategy.

· Subject matter expert on China registration requirements. Assisted team by identifying gaps in Chinese standard requirements for peripheral IV catheter products.

· Updated GUDID database for product portfolio.

· Two eSTAR 510k submissions including AI communication with FDA.

· Developed various internal regulatory documents that drive compliance to ISO standards and US regulations.

· Provided regulatory input and review to CAPA projects.

Regulatory Affairs core team member supporting global registrations and change control activities for Class I and II devices. Served as key liaison for APAC, EMEA, and EU market regulatory submissions during product lifecycle updates, manufacturing transfers, and business integration efforts.

• Managed international product registrations and renewals across APAC, Europe, EMEA, and China, ensuring uninterrupted global market access.
• Collaborated on regulatory strategy and implementation for a legal manufacturer change and site transfer from Indiana to Mexico during a corporate merger.
• Prepared Certificates to Foreign Government (CFGs), Declaration of Conformity (DoC), and technical documentation to support registration submissions.
• Reviewed and approved promotional materials for Class I and II US medical devices to ensure compliance with FDA regulations.
• Authored internal regulatory assessments and technical documents in support of labeling, risk management, and product change controls.
• Participated in internal audits and CAPA resolution, including projects focused on ISO 10993 biocompatibility compliance.
• Contributed to regulatory intelligence monitoring to track evolving global registration requirements and country-specific changes.