Cook Medical Names 30-Year Veteran April Lavender Senior Vice President, Regulatory Affairs, Cook Inc.BLOOMINGTON, Ind. -- April Lavender, a 30-year veteran of the Cook Medical organization with extensive experience in the company's medical device global regulatory affairs operations, has been named senior vice president, regulatory affairs for Cook Inc. Lavender was the vice president for regulatory affairs before taking on the title of senior vice president. April joined the Cook organization in 1976 where eventually she became the Manager for Operations of the Quality Control Department of the company. "When Cook first produced medical devices, the government and regulatory oversight was not as strong as it is today. Today we operate in a business environment where the cost of obtaining regulatory approval for a new product is often in the tens of millions of dollars," said Kem Hawkins, president of Cook Inc. and Cook Group Inc. "April Lavender's sterling leadership in this area has played a significant role in Cook's success at introducing not just new products, but entire new families of technologies such as our endovascular stent grafts, in the U.S. and most other major medical markets worldwide. I am proud to announce this promotion, and know that under her supervision our regulatory efforts will continue to help the company meet its promises to our customers and their patients." "This has been an extremely challenging and rewarding time to be involved in the regulatory affairs processes required to gain market approval for new medical devices," Lavender said. "Being named senior vice president at a company like Cook which puts the needs of the patients first and foremost is a genuine honor to me." Lavender has nearly three decades of experience in the medical device industry and is both a certified regulatory affairs professional (RAC See remote access concentrator. ) as well as a certified lead auditor. She is a member of the Indiana Medical Device Manufacturers Council (IMDMC IMDMC Indiana Medical Device Manufacturers Council ), the Regulatory Affairs Professional Society (RAPS), the American Society for Quality American Society for Quality (ASQ), formerly known as American Society for Quality Control (ASQC), is a knowledge-based global community of quality control experts, with nearly 100,000 members dedicated to the promotion and advancement of quality tools, principles, and Control (ASQ ASQ American Society for Quality ASQ Arab Studies Quarterly ASQ Automated Software Quality ASQ Administrative Science Quarterly ASQ Ages & Stages Questionnaires ASQ Allowable Sale Quantity ASQ Ascension Island (DoD radar) ) and the Society of Clinical Research Associates (SoCRA). She has participated in several public FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. advisory committee meetings and participated in compliance activities including Quality System (GMP GMP (guanosine monophosphate): see guanine. ) and Bioresearch bi·o·re·search n. Research in the biological sciences. Monitoring (BIMO) inspections on behalf of the Cook organization. About Cook The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK[R] (www.cookmedical.com/) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for drug-eluting and bare metal stents, aortic aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun) 1. the process or condition of becoming an embolus. 2. therapeutic introduction of a substance into a vessel in order to occlude it. coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and women's health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion