Bringing over 14 years of experience in the medical device industry, this biomedical engineer possesses a strong background in post and premarket regulatory affairs. Demonstrating motivation, efficiency, and exceptional organizational skills, this individual excels in navigating FDA guidance and adverse events, such as IDE, 510(k), PMA, Pre-Subs, De Novo, CAPA, and NCs. Leveraging advanced problem-solving abilities and extensive experience, this candidate is adept at overcoming challenges and adapting to shifting day-to-day priorities.
Overview
20
20
years of professional experience
Work History
Staff Regulatory Affairs Specialist
Embecta
06.2023 - Current
Participated in creating and refining the insulin delivery patch pump design.
Authored the insulin patch pump 510k and submitted through the eSTAR program
Prepared IDE submission leading to clinical trial approval for closed-loop insulin pump system.
Formulated regulatory strategies for new product launches.
Assessed regulatory impacts of changes in products and processes.
Built positive relationships by mediating discussions between company leaders and regulators.
Attended numerous pre-submission meetings with FDA.
Obtained state licenses to sell the insulin pump in all 50 states
Regulatory Affairs Manager
Accelerate Diagnostics
04.2022 - 05.2023
Represented company with government agencies to effectively obtain timely market authorization
Maintained product technical documentation and ongoing activities related to compliance with global regulatory directives and regulations
Provided regulatory support to project core teams
Reviewed and assessed design changes, product labeling, and product documentation for compliance and for regulatory implications
Performed regulatory compliance activities to maintain global compliance such as filing post-approval reports, health hazard evaluation reports, risk-benefit regulatory reports, reportable events, field action notifications, establishment registrations, and laser reports
Assisted in the education and broadening the regulatory knowledge within the internal teams
Authored, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities
Regulatory Affairs Program Manager
Philips
04.2020 - 04.2022
Participated in and advised cross-functional new product development teams on applicable regulations, requirements, and standards
Reviewed development quality reports and plans to ensure that the information required for submissions was adequate
Planned, generated, and coordinated regulatory submissions for product licensing
Reviewed and approved product labeling and marketing communications
Maintained existing regulatory filings/licenses, managed updates and related change control processes
Lead specific global projects as a core regulatory team member
Regulatory Operations Specialist
Philips
07.2018 - 04.2020
Lead EU MDR Regulatory team in writing fifteen Technical Files
Participated as a core team member for EU MDR compliance on cross functional teams
Responsible for delegating and tracking the regulatory EU MDR technical file work for eight regulatory team members to ensure critical timelines are met
Performed gap assessments comparing the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) to ensure products maintain their CE marking under the new EU MDR requirements
Worked with cross functional team to remediate gaps for EU MDR compliance
Supported cross functional teams with regulatory guidance for respirators and continuous positive airway pressure (CPAP) devices
Regulatory Affairs Specialist
Bard Peripheral Vascular
06.2014 - 07.2018
Participated in product development/line extension teams as required to ensure that the product was in compliance with all internal and external regulatory requirements
Developed, documents and implemented a regulatory submissions plan around product development/line extension goals
Prepared U.S
FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs
Prepared and updated European and international technical files/dossiers/registrations as required and per applicable SOPs
Reviewed Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards
Assisted Bard Corporate in updating establishment registrations and device listings as required
Ensured adequate documentation of Bard Peripheral Vascular's compliance to FDA, European and international regulations and standards
Ensured continuous update and maintenance of the Regulatory Affairs files
Developed working relationships with key personnel/representatives of the U.S
FDA Offices of Device Evaluation and Compliance and Bard Peripheral Vascular's notified body
Senior Regulatory Compliance Specialist
Stryker Sustainability Solutions
11.2013 - 07.2014
Supported post-market investigations through quality systems such as Post Market Heath Risk Assessments (PMHRA), Non Conformances (NC) Corrective And Preventative Action (CAPA), and Post-market Field Assessments (PFA)
Performed risk assessment and compliance review for non-conforming product and processes
Supervised and approved all Medical Device Reporting (MDR) for all division product complaints
Represented division as MDR Division Process Owner and was recognized as the only division in Stryker to file MDRs within FDA mandated time frame
Responded to FDA Additional Information requests related to device complaints and MDRs
Reviewed complaint investigations for accuracy and completeness
Assisted in the transfer of Lakeland complaint investigation lab to Tempe division headquarters
Performed, reviewed, and approved complaint device root cause investigations
Designed and implemented a training plan for new complaint investigation technicians
Trained all Trackwise Complaint Handling System (CHS) users and successfully launched CHS for the division
Trained Regulatory Compliance Analysts on regulatory reporting decision and MDR submission
Submit and review Engineering Change Requests and Engineering Change Order documents for the regulatory compliance team
Interacted with R&D and QA to review and approve testing procedures, protocols, and report
Regulatory Compliance Specialist
Stryker Sustainability Solutions
05.2013 - 11.2013
Supported post-market investigations through quality systems such as Post Market Heath Risk Assessments (PMHRA), Non Conformances (NC) Corrective And Preventative Action (CAPA), and Post-market Field Assessments (PFA)
Performed risk assessment and compliance review for non-conforming product and processes
Determined Medical Device Reporting (MDR) for all division product complaints
Represented division as MDR Division Process Owner and was recognized as the only division in Stryker to file MDRs within FDA mandated time frame
Responded to FDA Additional Information requests related to device complaints and MDRs
Reviewed complaint investigations for accuracy and completeness
Assisted in the transfer of Lakeland complaint investigation lab to Tempe division headquarters
Performed, reviewed, and approved complaint device root cause investigations
Designed and implemented a training plan for new complaint investigation technicians
Trained all Trackwise Complaint Handling System (CHS) users and successfully launched CHS for the division
Trained Regulatory Compliance Analysts on regulatory reporting decision and MDR submission
Submitted and reviewed Engineering Change Requests and Engineering Change Order documents for the regulatory compliance team
Interacted with R&D and QA to review and approve testing procedures, protocols, and reports
Regulatory Compliance Analyst
Stryker Sustainability Solutions
10.2008 - 05.2013
Reviewed all customer complaints on a daily basis to determine MDR reportability
Submitted all MDRs to the FDA within the mandated time frame
Responded to FDA 483 related to late MDR reporting and created a new training program and process to ensure on-time reporting
Generated engineering proposals with R&D for New Device Opportunity Assessments
Technical Sales Representative/Document Control Specialist
Polymicro Technologies
06.2005 - 10.2008
Provided customers with quotes and answers to their technical questions about optical fiber and fused silica capillary tubing in a timely manner by utilizing time management and organizational skills
Achieved monthly sales goals by traveling to customers' facilities to assist with product design and development
Increased new customer data base by attending trade shows and representing the company by providing potential customers with company and product information
Controlled all documents and procedures according to ISO standards
Represented company during customer, internal, and ISO audit