Tracy Lofgren

Experience

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  Hearthstone House

  Jan 2000 - Dec 2005

  General Manager

  • Directed all operations for boutique hotel in Aspen’s central core while managing an annual operational budget of over $300K.• Led successful efforts to define and implement critical customer service programs, increasing repeat business clientele by 300% over a six-year period.• Orchestrated marketing campaign by creating new brand image, designing website, and creating new marketing collateral materials. • Increased brand awareness and generated new business by attending global hospitality trade shows.• Established solid, revenue-producing relationships with corporations and targeted domestic and international travel wholesalers.• Recruited, staffed, trained, and evaluated hotel staff as well as administrated employee benefits.• Performed accounting functions such as accounts payable, accounts receivable, payroll, auditing and bank reconciliations using QuickBooks software. • Negotiated prices and purchased all facility operating supplies and services. Show less

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  Hearthstone House Properties

  Feb 2005 - Dec 2005

  Managing Broker

  • Created and managed real estate & property management company specializing in high-end rentals, including a hotel and luxury vacation home with a combined annual rental income of $750K.• Directed all aspects of short-term and long-term rentals including rental agreements, accounting, staffing, concierge services and maintenance.• Acted as Project Manager for two large-scale renovations by collaborating and negotiating bids with architects, contractors, and historic preservation associations.• Managed all aspects of company and client growth and development including copy-writing and photos selections for website, print ads and email marketing to brokerage firms and clients. Show less

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  Aspen Signature Properties

  Jul 2006 - Sept 2007

  Broker Associate
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  Ventracor

  Jul 2008 - Jul 2009

  Clinical/Regulatory Operations Associate

  Contributed to the successful completion of a US 140 patient, Bridge to Transplant trial and concurrent Continued Access BTT trial and randomized clinical trial for Destination Therapy for a Class III investigational device. Company dissolved in 2009.• Collected and maintained essential documents of participating centers to ensure compliance with Good Clinical Practice and all applicable regulatory requirements.• Ensure CFR requirements for adverse event reporting are established and being followed.• Developed and maintained tracking systems to ensure overall quality and completeness of in-house trial information including enrollment/screening logs, device implants, data collection schedules, study endpoints, adverse event reporting, protocol deviations, device inventory and internal/external staff training. • Supported Study/VAD Coordinators at participating centers with protocol, GCP and FDA 21 CFR regulation compliance, IRB submissions, approvals and renewals, data collection, and resolution of site-related issues.• Assisted in preparation of regulatory submissions to the FDA including progress reports, protocol amendments, supplements, labeling changes and product advisories. • Reviewed and/or modified informed consent forms and reference study materials to ensure compliance with 21 CFR Part 50.• Reviewed site monitoring reports for content and consistency and followed-up on action items. Show less

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  H.B. Fuller Medical Adhesive Technologies, LLC

  Sept 2011 - now

  Regulatory Affairs Consultant

  REGULATORY AFFAIRS CONSULTANT, Aspen, CO (March 2014 - Present)REGULATORY AFFAIRS SPECIALIST, Wyomissing, PA (September 2011 - March 2014)• Determine requirements and develop regulatory strategies for submissions, approvals and compliance activities.• Manage execution of required studies to satisfy the regulatory agencies; review and approve study protocols, coordinate lab testing schedules, develop and implement projects on time, and with appropriate quality and standards.• Prepare regulatory filings such as 510(k) Premarket Notifications, Design Dossiers, Technical Files as required to meet U.S. and international standards.• Negotiate/interact as appropriate with regulatory agencies during submission process, make decisions as to what is necessary to satisfy FDA reviewers to successfully pursue and obtain FDA submission approvals.• Collaborate with global regulatory partners to complete product registrations for new and modified devices, obtain Certificates of Foreign Government/Free Sale, review and approve product labeling.• Author, review, update and/or approve departmental Standard Operating Procedures, Work Instructions, and reference documents related to regulatory affairs.• Review and approve new and revised labeling and claims, advertising, and promotional materials for regulatory compliance.• Ensure compliance with aspects of the Quality Management Systems including document control, traceability, nonconformance, complaint handling and investigation, and supplier requirements.• Assess quality systems by performing internal audits to determine compliance to Quality System Regulations (QSR), assure compliance to established SOPs, make recommendations for improvement of quality systems based on audit findings and QSR or GMP requirements.• Receive, process, investigate, trend, document, identify corrective action plans and close customer complaints per regulatory requirements and company procedures. Show less

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  Aspen Signature Properties

  Jan 2015 - Nov 2015

  Broker Associate
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  Engel & Völkers

  Nov 2015 - now

  Real Estate Advisor/Luxury Rental Director
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  Christie's International Real Estate

  Dec 2020 - now

  Real Estate Broker