Biologics Consulting is seeking to hire a Medical Device regulatory expert with experience in software and digital health technologies.  This is a remote-based position.  This position involves working as a consultant directly with medical product companies to advise them on regulatory strategy, assist in the development of documentation to support premarket submissions, as well as the actual preparation and submission of premarket applications. Candidates should be problem-solvers with a strong scientific background, including knowledge of FDA guidance documents and regulatory policy in the area of software and digital health technology. Candidates must also have excellent interpersonal, oral and written communication skills, and be able to manage multiple competing pri