As our Regulatory Affairs Manager, Sara is responsible for ensuring that OC maintains regulatory compliance.
Background
With more than 17 years of experience in medical device Quality Management Systems and 20 years’ experience as a quality system auditor, Sara understands the intricacies of regulatory compliance. Sara has worked across all classes of medical devices, including orthodontics, battlefield trauma, and orthopedic implants and accessories. Sara is certified as an ASQ Biomedical Auditor, an ISO 13485/MDSAP Lead Auditor, and an ISO 9001 Internal Auditor, and has hosted numerous Notified Body audits and FDA inspections.
How This Role Helps You
In the ever-changing landscape of international medical device standards and regulations, OC relies on our partners to meet these evolving needs. Failure to maintain regulatory compliance can result in withheld orders, blocked parts, delayed launches, frustrated customers, and loss of business. Sara is working towards streamlining processes for licensing and registrations of OC products for each market where you sell. Her goal is to provide accurate information as requested in a timely manner to ensure our international partners are meeting their regulatory obligations.
About Sara
Sara enjoys being outdoors and can often be found fishing for salmon and steelhead in the beautiful Pacific Northwest. She is also one of the nicest people you will ever meet.
Thanks Sara for helping us recently on regulatory affairs.