Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-five years since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients internationally to address nonclinical, clinical, product development and manufacturing, and regulatory compliance challenges.
Biologics Consulting is seeking to hire a Medical Device regulatory expert with experience in software and digital health technologies. The candidate should have at a minimum a Bachelor’s degree in engineering or computer sciences, with at least 5-7 years of experience within FDA’s Center for Devices and Radiological Health or within the medical device software or digital health industries. Industry candidates must have extensive experience with the preparation and submission of FDA premarket submissions for digital health and software devices. Regulatory agency candidates must have direct experience with reviewing medical devices that contain software, with experience reviewing digital health products as a plus. Industry and FDA candidates who also have experience with quality systems and design controls are especially encouraged to apply.
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 priorities.
This is a full-time salary plus performance based bonus position.
Telecommuting is allowed.
Internal Number: 1027
About Biologics Consulting Group, Inc.
Biologics Consulting Group, Inc. is the leading regulatory consulting firm in product development and regulatory strategy for Biologics, Drugs, and Medical Devices. For over 25 years Biologics Consulting Group has supported clients in the preparation and review of CBER, CDER and CDRH regulatory applications, product development strategies, Quality (CMC) requirements, pre-clinical and clinical study designs, GLP/GCP/GMP audits, and strategic business planning.