Sarah Weber

About Sarah Weber

Are you trying to make healthy choices in your life but still feel exhausted, sore, or…

Experience

1. Global Corrections and Removals Expert

   Philips

   Nov 2021 — Present

   Work at a corporate level across various profit and loss centers to ensure compliant, consistent practices in Post Market Surveillance- Corrections and Removals. Manage teams of corrections and removals program managers and project leaders during extended vacancies in the Senior Manager role- Influenced and authored process changes to be adopted throughout the organization, including global recall reporting work instruction and decision tree template- Asked to lead the implementation of a new operating mechanism to elevate and streamline correction and removal decision-making corporate wide- Approved correction and removal project documentation including but not limited to 806 Submissions, FDA monthly status report, termination requests, strategy documents and project closure documentation- Partnered with Risk Management to ensure consistent post market risk evaluations- Lead special project team to create corrections and removals/recall competency training for those directly involved in the process, upstream and downstream of the process and those accountable for corrections and removals/recalls- Supported Imaging businesses in recall decision making, reviewing supporting risk and investigation documents to ensure well supported recall decisions, participant in decision-making discussions on when to take a correction or removal, review recall notices- Participant in team to review and recommend current to future state risk documentation changes/improvements- Wrote and presented material to internal audit team on global recall regulations and the role risk plays in meeting those regulations- Represent the recall function at compliance review meetings in place of the director- Supported FDA inspections as needed for multiple facilities globally- Participated in annual review process of employees- Attended and provided data for quality management reviews- Lead weekly corrections and removals project review meeting.

Education

• Trinity College of Natural Health

  Doctor of Naturopathy

  2010 — 2014

• CNHP

  Certified Natural Health Professional

• Marquette University

  Bachelor of Arts (BA)

  1993 — 1999

Skills

• Strategy
• Cross-Functional Team Leadership
• Iso 13485
• Fda
• Medical Devices
• Capa
• Regulatory Affairs
• Design Control
• Regulatory Reporting
• Quality Assurance
• Regulatory Submissions
• Healthcare
• Leadership
• Quality System
• Regulatory Filings
• Regulatory Requirements
• Corrective and Preventive Action (Capa)
• Management
• Regulations
• U.s. Food and Drug Administration (Fda)
• Product Development
• Regulatory Risk
• Regulatory Strategy