Seasoned Industry Veteran to Play Critical Role in Assessing Regulatory and Quality Impact on Overall Corporate Strategy and Operations
OmniGuide Appoints Sharon Timberlake VP Regulatory Affairs and Quality Assurance
OmniGuideBrad Smith, 617-551-8420CFO
OmniGuide, Inc., a commercial stage medical device company, today announced the appointment of Sharon Timberlake as VP of Regulatory Affairs and Quality Assurance. Timberlake has substantial experience in the medical device industry including surgical laser systems and women’s health. Her experience and expertise will be essential to providing leadership on regulatory affairs, clinical affairs and quality assurance as well as new product development and manufacturing as she works with the management team to define the strategic direction of the company and drive business growth.
"With an extensive background in regulatory, quality and clinical, involving both Class II and Class III medical devices, Sharon is a great addition to our experienced management team," said Scott Flora, CEO of OmniGuide. “Her background in medical lasers and with women’s health companies coupled with industry credibility gained through her appointment as an industry representative on an FDA advisory panel, is highly relevant to OmniGuide as we enter this next phase of our strategic growth plan.”
Ms. Timberlake most recently served as VP Global Regulatory Affairs and Quality Affairs for Palomar Medical Technologies, a medical device company specializing in aesthetic and general surgical light and laser devices. She was previously Manager Clinical, Regulatory and Quality Affairs at Biosphere Medical, Clinical Research Project Manager for Assurance Medical and Clinical Research Monitor for Summit Technology.
Ms. Timberlake serves as an industry representative for the General & Plastic Surgery Device Advisory Panel at the Food & Drug Administration.
Ms. Timberlake received her MS in Health Sciences, Clinical Leadership from George Washington University of Medicine and Health Sciences and her BS in Business Administration from Fitchburg State University.
"I was attracted to OmniGuide by a highly differentiated product offering that has the potential to make a big difference in patient care," said Ms. Timberlake. “I look forward to applying my skills and expertise in regulatory, quality and clinical to help advance OmniGuide’s business.”
OmniGuide advanced surgical energy systems combine the value of CO lasers with unprecedented precision, control and access. For physicians across different disciplines, OmniGuide offers safe, precise cutting and ablation of soft tissue.
In microsurgery, laparoscopy and robotic procedures, OmniGuide systems deliver CO laser energy through unique flexible optical fibers, with the potential to improve patient outcomes as a result of enhanced precision and less damage to tissue around the surgical site.
Major medical centers across the United States are using OmniGuide systems in procedures ranging from Gynecology to ENT and general surgery.
OmniGuide, Inc. is a leader in the development and marketing of advanced surgical energy solutions for minimally invasive surgery that improve precision, access and control. OmniGuide’s products are sold under the BeamPath® brand and are clinically targeted for superior clinical outcomes in Gynecology and ENT. The Company distributes its products in the U.S. through a direct sales force. OmniGuide is committed to developing products that improve and expand surgical treatment options, enhance clinical outcomes, and reduce treatment complexity and cost.
Additional information about OmniGuide may be found at .