Jen Anderson Email and Phone Number
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Jen Anderson personal email
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.
Imagemover
View- Website:
- imagemovermd.com
- Employees:
- 22
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Vp Of Regulatory And Compliance; Management Representative; Privacy, Security And Data Protection OfficerImagemoverMadison, Wi, Us
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Vp Of Quality Management, Regulatory And ComplianceImagemover Jul 2018 - PresentMadison, Wisconsin, 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.
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Regulatory Project ManagerForte Research Systems, Inc. Jan 2015 - Jun 2018Madison, Wi, Us• Performs all document control activities, works with all Forte team members to collect Quality Management System (QMS) & Information Security Management System (ISMS) inputs and updates existing process, work instruction and guidance documentation.• Implemented a new Learning Management System (LMS) and manages tool and all QMS training activities.• Develops new tools to support QMS implementation (new guidance docs, flowcharts, etc.)• Updates and creates customer facing documentation related to Forte compliance and regulatory affairs.• Manages and performs all HIPAA and 21 CFR Part 11 onboarding and ongoing training.• Manages ISO 9001 & ISO 27001 Certifications.• Leads the completion of annual QMS monitoring activities including performing annual security audits, vendor qualifications, annual vendor audits, risk assessments, HIPAA audits, management review, internal audits of our QMS and ISMS and response and recovery rehearsals.• Manages corrective and preventive action (CAPA) process, works with team leadership to identified resolutions to audit findings.• Manages all audits conducted by external organizations such as prospects, customers, registrars for external certifications and contracted consultants. -
Software Engineering Quality SpecialistIkaria, Inc. - Now A Part Of Mallinckrodt Pharmaceuticals. May 2012 - Jan 2015Hampton, Nj, UsI am responsible for assuring that activities, processes, and specified conditions related to the daily design and manufacturing operations meet cGMP standards and comply with applicable procedures and standards to ensure the quality integrity of assigned product(s).I support engineering and manufacturing groups in the execution and completion of project deliverables and any efforts towards quality improvements. I utilize critical and statistical thinking and methodologies to identify nonconformance and opportunities for improvement. I am involved in planning improvements, executing those plans, and then follow up to ensure desired results have been satisfied, especially with regard to meeting safety, quality, and regulatory requirements. I participate in and support activities involving compliance with applicable regulatory and Quality Management System requirements. -
Regulatory Affairs EngineerAccuray, Inc. (Formerly Tomotherapy Inc.) Jun 2011 - May 2012•Establishes procedures to ensure the quality system meets the requirements of national and international regulations.•Monitors the various product feedback systems to ensure that applicable issues are investigated as customer complaints.•Coordinates the investigation of customer complaints; ensures that complaints are properly investigated and documented.•Prepares and submits reports of adverse events to national and international regulatory agencies.•Performs internal quality audits. •Prepares for and participates in external quality system audits.•Prepares, submits and manages product applications necessary to seek product marketing approval. •Assists other departmental personnel as needed with regulatory matters; trains employees as needed on regulatory matters.•Participates in product risk management and hazard analysis activities to help identify product risks and ensure that mitigations are appropriate.
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Regulatory Affairs EngineerTomotherapy Nov 2008 - May 2011Madison, Wisconsin, Us•Establishes procedures to ensure the quality system meets the requirements of national and international regulations.•Monitors the various product feedback systems to ensure that applicable issues are investigated as customer complaints.•Coordinates the investigation of customer complaints; ensures that complaints are properly investigated and documented.•Prepares and submits reports of adverse events to national and international regulatory agencies.•Performs internal quality audits. •Prepares for and participates in external quality system audits.•Prepares, submits and manages product applications necessary to seek product marketing approval. •Assists other departmental personnel as needed with regulatory matters; trains employees as needed on regulatory matters.•Participates in product risk management and hazard analysis activities to help identify product risks and ensure that mitigations are appropriate. -
Integration Test Engineer/Design Qa EngineerTomotherapy May 2006 - Nov 2008Madison, Wisconsin, UsI'm an expert bug hunter that tests software and occasionally hardware components during the development of the product. My mission is to find important bugs early. I am responsible for continuous testing during the development phase, formal integration testing, verification of bug fixes, and generation of test reports. I am able to think analytically, troubleshoot quickly, and design tests cases on the fly.
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Software Qa EngineerEmageon (Formerly Ultravisual) Mar 2003 - May 2006Responsible for making sure the test cases reflect the ongoing functionality and keeping the test cases and test plans abreast for any new changes in functionality. Report software defects and verify fixes. Worked closely with developers testing new code on the fly. Provided thorough knowledge of our home grown defect tracking tool, revision control software, traceability methods, and quality metric programs. I was with UltraVisual Medical Systems when they merged with Emageon (PACS & Archive) in April 2004.
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Marketing Communications ManagerPhilips Medical Systems (Formerly Adac Laboratories) Apr 1995 - Mar 2003Managed all aspects of marketing materials for PROS (Philips Radiation Oncology Systems) division. Assisted with RFP’s. Proven organizational leadership and interpersonal skills. Managed all department trade shows including: booth design/layout, graphics, handouts, travel arrangements/attendance, user meetings and parties, trainings, demo schedules, customer satisfaction surveys, wrap-up meetings, and lead generation/distribution. Managed entire department price book and pioneered efforts to transition to Siebel application. Managed yearly department advertising budget and was point of contact on all accounts. Strong interpersonal skills and proven success communicating with cross-functional internal and external teams.
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Software Quality Assurance EngineerAdac Laboratories (Formerly Geometrics) Jan 1995 - Apr 2000Verified checkins, generates, executes and documents test plans and the quality system. Responsible for Y2K testing efforts. Researched & designed system and case specifications to match the needs of department. Excellent team player with very positive “can do” attitude. I was previously with Geometrics Corp. which was purchased by ADAC Labs. and then purchased by Philips Medical Systems.
Jen Anderson Skills
Jen Anderson Education Details
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Madison Area Technical CollegeComputer Programming -
Verona High School
Frequently Asked Questions about Jen Anderson
What company does Jen Anderson work for?
Jen Anderson works for Imagemover
What is Jen Anderson's role at the current company?
Jen Anderson's current role is VP of Regulatory and Compliance; Management Representative; Privacy, Security and Data Protection Officer.
What is Jen Anderson's email address?
Jen Anderson's email address is je****@****ria.com
What schools did Jen Anderson attend?
Jen Anderson attended Madison Area Technical College, Verona High School.
What are some of Jen Anderson's interests?
Jen Anderson has interest in Compassionate With The Aged, Turkey Hunting, Spending Time With Family And Friends, Fishing, Softball, Personal Interests, Children, Gardening, Be Kinder Than Necessary, Environment.
What skills is Jen Anderson known for?
Jen Anderson has skills like Quality Assurance, Testing, Medical Devices, Fda, Cross Functional Team Leadership, Visio, Quality System, Software Documentation, Iso 13485, Process Improvement, Training, Sharepoint.
Who are Jen Anderson's colleagues?
Jen Anderson's colleagues are Richard (Tim) Adams, Matthew Baker, Haley Knapp, Marcie Loonam, James Franco, Michael Samm, Wendt Gary.
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