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 priorities.

This is a full-time salary plus performance-based bonus position.

Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices.  In the twenty-nine 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.

The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience. Biologics Consulting offers a great work environment, as well as a highly competitive salary and benefit package, including healthcare, 401k, with 3% employer match and ESOP plans.

Biologics Consulting Group, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.

As a federal government subcontractor, Biologics is subject to any federal vaccine mandates or other vaccination requirements.  As such, any offers of employment will be contingent upon COVID-19 vaccination or an approved accommodation.  All new hires are required to report their vaccination status.

Applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

To learn more about Biologics Consulting Group, Inc. please visit our website at: www.biologicsconsulting.com

The successful 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.