Olivia Koehler

Experience

• 

  BYRON J. ROUND, DDS, PC

  Jan 2008 - Sept 2013

  Orthodontic Assistant

  Perform clinical orthodontic functions, including: x-rays, records, bonding/debonding, adjustments, and archwire replacements.Perform administrative functions, including: scheduling, patient management, and reception, as needed.

• 

  Precision Appliances Lab, Inc

  May 2012 - Nov 2017

  Create training documentation and program for CAD processesCreate regulatory documentation (GxP) in accordance with FDA, ISO, DAMAS, OSHA, and other regulatory standards

  • Director of Digital Dentistry

    Sept 2016 - Nov 2017

  • Marketing and Office Manager

    May 2012 - Nov 2017
• 

  DoubleTime Ortho, LLC

  Aug 2017 - Jun 2023

  Owner, Director
• 

  NEOLab (New England Orthodontic Lab)

  Nov 2018 - now

  NEOLab is a leading, full service orthodontic laboratory with a wide range of functional orthodontic appliances. By partnering with NEOLab, general dentists, pediatric dentists, and orthodontists gain access some of the highest quality devices and efficient workflows in the industry. In this role, my responsibilities and achievements have included: - Performing market research to define industry trends and growth patterns from leading contributors, both from the provider and consumer perspectives- Creating and leading long-term marketing projects, including the development of social media pages and schedules, leading B2C product discussion groups, and developing individual product branding guides - Defining and developing the NEOLab, NEOLab Jr, and product family brand voices in a cohesive tone- Overseeing and managing strategic content/marketing B2B partnerships with other industry leaders - Creating key marketing content for products, processes, and problems (Gain new customers and help lead our existing consumer base) - Tradeshow development and management for approximately 15 shows per calendar year - Developing and managing content libraries- Optimize content for SEO Show less NEOLab is a premier orthodontic laboratory, who functions to create orthodontic medical devices used in conjunction with treatment plans provided by licensed general dentists, pediatric dentists, and orthodontists. As part of my dual role at NEOLab, I have been responsible for: - Building a fully FDA 21 CFR 820 compliant quality management system from the ground up - Developing and implementing quality programs, including CAPA, internal audit, training, inventory and supplier qualification, equipment qualification, and compliant trending - Submitting two 510(k)s, both granted by FDA- Lead FDA on-site inspections as management representative - Regularly report to top management concerning trending regulatory issues and provide recommendations for improvement or resolution - Currently evaluating the program and implementing changes for adherence to ISO 13485: 2016 and FDA QSMR- Serve as regulatory SME- Pass Regulatory Affairs Certification (RAC) exam for medical devices Show less

  • Content Director

    Nov 2018 - now

  • Regulatory Director

    Nov 2018 - now

  • Document Control Coordinator

    Nov 2018 - Oct 2021