Lolli Olsen

Experience

• 

  Durable Medical Equipment | Regulatory Affairs | Manufacturing

  Jan 1994 - now

  Regulatory Affairs | Complaint Resolution Specialist | Supervisor

  I am a highly experienced Regulatory Affairs / Complaint Resolution Specialist with extensive product knowledge of durable medical equipment.

• 

  Invacare Corporation

  Jan 1994 - Jan 2017

  Led the Complaint Handling Unit to ensure that standard practices and processes were followed on the review of product complaints received from the various channels including end-users, dealers and the FDA. Supervised a team of up to 72 associates.• Performed daily analysis of trend reports for complaints and provided appropriate data for review by management. • Served as primary subject matter expert for all FDA, third party, and ISO audits/inspections for US, Canada, China and Europe.• Reviewed complaint records and filed Medical Device Reports (MDR) to the FDA.• Authored and implemented white papers that resulted in a 25% reduction in complaint records.• Collaborated with customer-facing Department Managers to develop, plan and revise procedures used to track and record complaints into the systems tools. • Managed remediation of 100,000 Class I and II medical device complaint records. • Developed, maintained, updated and recommended improvements for the complaint process management system.• Worked collaboratively with Invacare location teams that have exposure to customer complaints to ensure consistent practices and application of approved Invacare complaint handling process.• Authored and updated complaint handling procedures and provided training to the Complaint Handling Unit.• Led cross-functional teams and projects related to complaints and product defects.• Served as auditor of EtQ complaint handling software.• Ensured the development of team members, provided appropriate coaching, and conduct performance reviews.• Established performance metrics to monitor individual team member performance and organizational performance regarding the processing of complaints.• Analyzed and trended Key Performance Indicators (KPI's) on productivity and quality.• Led project to eliminate paper files and go to completely electronic files. • Planned activities and team building for department. Show less Managed Adverse Event Complaint Files. Reviewed Complaint File data as received for timeliness and correct data collection for FDA and Health Canada reporting. Supervised a team of seven.• Developed thorough knowledge including practical application of 21CFR Part 11, 820, and ISO13485. FDA Regulation experience.• Worked collaboratively with Legal Department, Regulatory Affairs, Quality Systems, and Corporate Quality to investigate complaints to closure. • Trended MDR and Adverse Event Complaints providing vital statistics for Safety Committee review and decision making.• Provided management with gap analysis to the Quality Management System and provided recommendations to improve efficiency.• Provided management feedback on critical issues and facilitated problem solving until resolution. Show less Served as Subject Matter Expert for Law Label Licensing. Administrator for TrackWise and NetRegulus. • Successfully planned and implemented NetRegulus and Trackwise Quality Management Software Systems• Obtained TrackWise knowledge through advanced training and conferences. Provided system functionality training to associates.• Entered complaints into NetRegulus and TrackWise.• Completed and filed Medical Device Reports with the FDA.• Worked collaboratively with Manufacturing Plants, Customer Research Department, TBM's, dealers, Tech Services and Regulatory Affairs Show less

  • Supervisor, Complaint Handling Unit

    Jan 2012 - Jan 2017

  • Product Complaint Specialist

    Jan 2011 - Jan 2012

  • Regulatory Affairs and TrackWise Administrator

    Jan 1999 - Jan 2011

  • Quality Returns Coordinator | Transportation Coordinator | Customer Service Coordinator

    Jan 1994 - Jan 1999
• 

  IBM Watson Health - Imaging

  Jan 2018 - Jul 2022

  Post Market Surveillance Compliance Manager

  Manage a team of Quality Compliance Specialists whose main function is to evaluate all issues for Watson Health/Merge Medical Device products (21 CFR 820.198). Ensure compliance with regulations and Merge's internal Quality Management System. The team is responsible for evaluating and reporting (MDRs) to the FDA (21 CFR 803) and escalates any issues that could potentially result in a field action or recall per 21 CFR 806. The Designated Complaint Handling Unit strives to create an atmosphere of positive and effective cross functional communication with Customer Support, Services, R&D, RA/QA & Project Management. Complaint trend information is distributed within the organization to assist in affecting change and improve Watson Health/Merge's processes, people and products. Show less

• 

  Merative

  Jul 2022 - now

  Post Market Surveillance - Medical Devices