Clinical Affairs Director
Current• Work in conjunction with R&D, Regulatory, Quality, Marketing, and Manufacturing to develop and bring new products to market, includes support of 510K applications, clinical validation and user preference studies. Support clinical research projects.• Maintain strong relationships with marketing, sales, clinical, marketing communications, and partners.• Plan and understand overall business strategy, market and business development, Salter product family, and the critical role of upstream marketing in cross-functional collaboration in driving business success – leading and driving the performance and engagement of teams while developing sales talent capability. • Support the Quality & Regulatory Division with product complaints, recalls and MDR filings. Support labeling efforts to meet the latest domestic and international requirements. • Create the post-market clinical evaluation reports and post-market surveillance reports for Salter products families to adhere to the latest medical device regulations. Support internal and BSI audits.• Support sales efforts through educational and sales tools, product training, and evidence-based research.