Summary
Overview
Work History
Education
Skills
Websites
Timeline
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Laurie Sang

Mesa,AZ

Summary

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

Education

Bioengineering - Biomedical/Medical Engineering

Arizona State University
05-2005

Skills

  • CAPA
  • ISO 13485
  • Complaint Management
  • FDA
  • Medical Devices
  • Quality Assurance
  • Quality System
  • Regulatory Affairs
  • Customer Service
  • Sales

Timeline

Staff Regulatory Affairs Specialist

Embecta
06.2023 - Current

Regulatory Affairs Manager

Accelerate Diagnostics
04.2022 - 05.2023

Regulatory Affairs Program Manager

Philips
04.2020 - 04.2022

Regulatory Operations Specialist

Philips
07.2018 - 04.2020

Regulatory Affairs Specialist

Bard Peripheral Vascular
06.2014 - 07.2018

Senior Regulatory Compliance Specialist

Stryker Sustainability Solutions
11.2013 - 07.2014

Regulatory Compliance Specialist

Stryker Sustainability Solutions
05.2013 - 11.2013

Regulatory Compliance Analyst

Stryker Sustainability Solutions
10.2008 - 05.2013

Technical Sales Representative/Document Control Specialist

Polymicro Technologies
06.2005 - 10.2008

Bioengineering - Biomedical/Medical Engineering

Arizona State University
Laurie Sang