Medical Device Regulatory Expert

Medical Device Regulatory Expert

Biologics Consulting is seeking to hire a Medical Device regulatory expert. The candidate should have at a minimum a Bachelor’s degree in engineering, chemistry, physics, or the biological sciences, with at least 4 years of experience within the medical device industry or a national regulatory agency such as the Food and Drug Administration. Industry candidates must have extensive experience in the preparation and submission of FDA premarket submissions, including 510(k)s, IDE’s and PMAs. Regulatory agency candidates must have been directly involved in the review of premarket submissions. Experience with medical device quality systems or knowledge of EU medical device regulatory is a plus.

This position involves working as a consultant directly with medical device 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 their area of scientific expertise. 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 consulting position.

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.

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, and ESOP plans.

Biologics Consulting Group, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability.