Toronto-based Titan Medical Inc. announces the appointment of Tammy Carrea as vice president of quality and regulatory affairs.

“We are delighted that Tammy has joined Titan Medical’s leadership team as we advance our Enos robotic single access surgery system toward human clinical studies,” says David McNally, president and CEO. “Her proven track record in developing and implementing clinical and regulatory strategies, obtaining medical device regulatory clearances and successfully managing FDA inspections will be invaluable assets for Titan.”

“It is my pleasure to welcome Tammy to Titan and I look forward to working with her as we progress toward submitting our application for Investigational Device Exemption for the Enos system to the FDA.”

Carrea has more than 25 years of experience in managing quality assurance and regulatory affairs activities in the medical device industry, including robotic assisted surgery. She has been responsible for global submissions and registrations for Class 1, 2, and 3 medical devices including De Novo applications.

Most recently, she served as vice president, regulatory and clinical affairs and security officer of Translational Imaging Innovations, Inc., which produced software for ophthalmology medical imaging and cloud data management to enable AI algorithm development.

“I am thrilled to join Titan’s impressive leadership team during such a pivotal time in the company’s evolution,” says Carrea. “I look forward to applying my background and experience to help the company to realize its vision for commercializing its Enos robotic single access surgical system for the benefit of patients, while enhancing the surgical experience for surgeons and hospital staff.”

Curtis Jensen, Titan’s vice president of quality and regulatory affairs since April 2017, leaves the company to pursue other opportunities in the medical device industry. “We thank Curtis for his contributions to the development program for the Enos system,” says McNally. “Curtis commuted a long distance to Chapel Hill while the company established a team to advance the development of the Enos system. We wish Curtis the best in his future endeavors.”