Greater Minneapolis-St. Paul Area
My experience in medical devices involves working in a Level 1 Trauma Operating Room Department, on the road with the American Red Cross, Regulatory Affairs, and even using medical devices in Iraq during Operation Iraqi Freedom. From holding and using the devices in my hands to consulting clients interested in bringing new products to market - medical devices are my passion.
Deep Brain Stimulation regulatory • Submitted multiple EU MDR Class III Active Implantable and Non-Implantable Technical Documents • Collaborated with stakeholders to author FDA Master Files • Assessed changes and submitted FDA 30-days and Annual Reports Neuromodulation regulatory • Regularly assess changes for impact on business • Support for international registrations and renewals • Management of OEM device approvals • Global changing regulation intelligence and communication • Review Advertising and Promotion materials for compliance • Fulfillment of supply chain regulatory partnerships
• Individually authored multiple simultaneous 510(k) submissions • Ensured international Food & Beverage industry compliance with a focus on BSE/TSE and plastics • Reviewed Technical Files for EU MDD submission • PPE EUA consultation for face masks, surgical masks, and respirators including NIOSH guidance
• Broad and growing experience in medical device EU MDR • 510(k) planning, drafting, compilation, and submission • Reviewed STEDs/Technical Files for MDD to MDR gaps • Clinical Evaluation Plan and Report drafting, including full literature review • International regulatory pathway compliance • Evaluated Quality Management System documentation for ISO 13485 and ISO 14971 • Reviewed quality manuals to establish compliance to applicable standards; revise quality operating procedures and work instructions • Creative collaboration with joint venture startup project planning, while disseminating critical and complex information in a comprehensive and effective manner that is easily understood • Delivered comprehensive guidance on State of MN Laboratory compliance and CLIA regulation - Waived, Moderate, and High Complexity
• Interpreted the needs of surgeons and medical staff from Orthopedic, Neuro, Spine, URO/GYN, Cardiovascular, Plastics, ENT, and General services using direct communication • Ensured Level 1 Trauma Operating Rooms have 100% accurate and appropriate supplies for specific patient procedures • Utilized consistent cost-saving methods such as minimizing supply waste and unnecessary costly actions
• Employed decision making and critical thinking skills in stressful situations • Demonstrated the ability to accept correction, learn new tactics and skills quickly, perform duties with minimal supervision, and improvise when resources were low or non-existent • Communicated and collaborated with superiors utilizing comprehensive documenting and record keeping practices • Experience in providing treatment in trauma, triage and advanced field care under combat conditions