The Spectranetics Corporation (Spectranetics) has promoted Michael Handley to vice president, global regulatory affairs and compliance of the company. Spectranetics has appointed Elaine Messa to the company as interim chief compliance officer, also a newly created, contracted position. In their new roles, Both will report directly to Geisenheimer.
Michael Handley is a director, global regulatory affairs and compliance of the Spectranetics.
“The appointments of Mike and Elaine are another step in our ongoing commitment to continuous improvement in Spectranetics’ compliance programs,” said Emile Geisenheimer, chairman, president and chief executive officer.
Handley comes to Spectranetics in April 2007 as Manager of Regulatory Affairs and was promoted to director, global regulatory affairs and compliance in August 2007. Before joining Spectranetics, he served as vice president, regulatory affairs for AccelaPure. Before that, Handley was senior principal at Pittiglio Rabin Todd & McGrath, a nationally recognized management consulting firm for the biopharmaceutical and medical device industries and a founder of Actus Partners, a consulting firm providing services in the areas of drug discovery, development and regulatory affairs. Handley graduated cum laude from Colorado State University with Bachelors of Science degrees in Molecular Biology, Physiology, and minors in Chemistry and Neurobiology.
Messa comes to Spectranetics from Becker & Associates Consulting, Inc., where she serves as director of the medical device quality systems and compliance practice group, overseeing all medical device engagements related to compliance with the Food and Drug Administration (FDA) regulations. Before joining Becker & Associates Consulting, Messa held multiple roles during a 30 year career at the FDA, the last 16 of which were in management positions within FDA district offices. During her FDA tenure, she successfully established an industry grass roots group and developed technical joint training efforts with local regulatory associations. Messa chaired the Office of Regulatory Affairs/Center for Devices and Radiological Health (CDRH) Medical Device Field Committee, representing field activities and interests within CDRH. She participated in the development and implementation of regulations, guidance, policy, and compliance programs, including the Medical Device Quality System Regulation, Medical Device Mutual Recognition Agreement, Warning Letter Pilot, and Quality System Inspection Technique.