Jen Anderson

About Jen Anderson

I am a quality, regulatory affairs and compliance leader with over 2 decades of experience in many aspects of Medical Device and Bio-pharmaceutical sectors across all elements of Product Development, Manufacturing, Project Management, Development of Specifications and Requirements, Statistical Quality Assurance & Quality Control, Technical Writing, Marketing, Process Development for Adherence to FDA\'s 21 CFR Part 820, Part 11, and ISO 9001, ISO 27001, ISO 13485, QSR Training Programs including: one-on-one & classroom settings, Coordination of 510(k) Submissions to the FDA for Medical Devices, Complaint Handling, CAPA, IQ, OQ, PQ, Quality Auditing, Standard Operating Procedures (SOP), Risk Assessments, Business Continuity, Disaster Recovery, Strategic Planning, Project Management, US FDA Good Manufacturing Practice (GMP), Team Building, Execution and Delivery of Projects on Time, Canadian Medical Device Regulation, Privacy and Security Laws for the US (HIPAA), European Medical Device Directive, Internal Auditing (Certified Lead ISO 9001:2015 Auditor) and Supplier Evaluations/Vendor Management. Notarized since April 26th, 1990 (Commission Expires: August 03, 2026)My experience spans from start-up to IPO and beyond at various company sizes. I have a hands-on style with a focus on developing people, processes and a commitment to excellence. I identify myself as a goal oriented professional who has high ambitions in life and high expectations from myself. By utilizing a reasonable and balanced approach I have proven capabilities to be a catalyst for change and enable the consistent delivery for exceeding expectations. I have the ability to balance short term objectives with mid to long term strategy in a highly dynamic and challenging operating environment. Demonstrated success in change management, systematically affecting organizational turnaround via disciplined transformation methodologies resulting in a more adaptive organization, ensuring high levels of colleague engagement. I am a highly effective and adaptable communicator and net-worker, comfortable with change and role ambiguity.

Experience

1. VP of Quality Management, Regulatory and Compliance

   Imagemover

   Jul 2018 — Present · Madison, WI, US

   Develop, define, document, maintain and manage all regulatory and compliance tools, policies and procedures, with the goal of being ISO 9001 & ISO 27001 certified.• Works with the ImageMover team to define new and update existing processes, work instructions and guidance documentation.• Provides ongoing leadership to Team Members: helps prioritize projects, tasks and assignments. Collaborates and approves QA V&V reports and other QA SDLC outputs. Champions for additional resources when necessary, highlights process throughput and encourages process development to ensure efficiency between development and QA teams. Facilitates Change Control Board (CCB) meetings. • Onboarding/Offboarding and Internal QMS training, tracking and gap assessment. • Internal QMS Audits - Coordinate and lead associated reviews, improvement activities, internal audits, and work with customer and resellers/partners as it relates to safety, quality, privacy, and regulatory requirements.• Vendor Audit Management• External Audit Management (ie: ISO)- Quality Management System - Designated as ImageMover’s Management Representative, implements policies based on current Quality Management standards (ISO 9001). Manages and coordinates all external audits and works to maintain ISO certifications.• Document Control Management – Develop and implement a document control process.• CAPA Management • Quality Monitoring & Measurement – Identify value adding metrics that are likely to indicate the health of our organization. Tracks metrics so the organization can respond as necessary to important and critical situations.• Disaster Recovery & Business Continuity• Information Security Management – Designated as ImageMover’s Privacy, Security, & Data Protection Officer, implements policies based on current Information Security standards (ISO 27001). • Monitoring Standards, Statutes and Regulations – subscribes to FDA and other sources to receive updates on standards, statues and regulations.

Education

• Madison Area Technical College

  Computer Programming

Skills

• Requirements Gathering
• Cross-Functional Team Leadership
• Software Documentation
• Sdlc
• U.s. Food and Drug Administration (Fda)
• Digital Imaging
• Visio
• Linux
• Medical Imaging
• Manufacturing
• Medical Devices
• Iso 13485
• Software Project Management
• Clearcase
• Gmp
• Requirements Analysis
• Validation
• Software Development
• Dicom
• Business Process Improvement
• Fda
• Electronics
• Erp
• Training
• Sharepoint
• Testing
• Sap
• Test Planning
• Product Development
• Analysis
• Program Management
• Process Improvement
• Software Engineering
• Troubleshooting
• Quality System
• V&V
• Integration
• Process Simulation
• Six Sigma
• Product Launch