email@example.com P: 216-455-1435
Our client is a leading Midwest law firm. Their HealthCare and FDA practice advises clients on FDA regulations governing the marketing, advertising, labeling, manufacturing, exporting, and development of regulated products. They provide advice to clients when obtaining product approvals and conducting clinical studies, as well as when the need arises to undertake corrective actions, such as product recalls or withdrawals. Clients include manufacturers and distributors of medical device, biopharma, health IT, and food and agriculture markets and health care providers.
Required: Three to six years of FDA experience, including; regulatory approval and clearance, regulatory inspections and audits, labeling, marketing and commercialization, and quality system and operational matters. Experience addressing FDA compliance review in health care industry transactions, such as mergers and acquisitions, joint ventures, commercial agreements, and license and lease agreements
Please reference Job Code 5342 BW when responding to this position. Please send your resume as an attached document in Word form.