FDA Digital Health/Medical Device Attorney

Richmond office of a BCG Attorney Search Top Ranked Law Firm seeks an FDA digital health/medical device attorney with 1-year of experience. The candidate will play a key role in helping clients launch new products and platforms, build innovative business models, protect their brand and trade secrets, hire key talent, and understand how the rapidly changing technology and policy landscape will impact their business. Using substantive FDA regulatory law expertise and creative problem-solving skills will help position clients to turn passion and vision into reality and ultimately improve human lives. It's a bonus to have significant experience in one or more of these areas Digital health and telemedicine, Post-market surveillance, Regulatory investigations, Supplier evaluation, Import/export activities, Software Development, and Healthcare reimbursement. Must have experience interfacing with the FDA through the device regulatory pre-submission and submission processes. Must have experience in navigating the ever-changing healthcare regulatory landscape.

The candidate must have expertise in advising clients on market authorization strategies for medical devices and mobile/digital health technologies (including Software as a Medical Device). Must have an understanding and ability to support clients in developing quality management systems and pre-clinical/clinical study designs. Must have the ability to identify and evaluate legal and business risks and opportunities for healthcare companies. Must have a keen interest in and curiosity about healthcare innovation. The firm offers benefits that include platinum-level health insurance and HSA, FSA, dependent care, dental and vision insurance, short-term disability insurance, 401(k) with match (after the first year), a home office allowance, and a PTO policy which includes paid holidays, vacation time, and parental leave. Total compensation includes base salary (based on experience) for a minimum of 25 hours billable per 40-hour work week, quarterly compensation based on project management, annual performance bonus, and origination credit.