Biologics Consulting is seeking to hire a Medical Device Senior Consultant, preferably with experience with in vitro diagnostic device and companion diagnostic technologies. The candidate should have at a minimum a Master’s degree in engineering, chemistry, physics, or biological sciences, with at least 7 to 10 years of experience within FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR/OIVD) or within the medical device industry. 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 direct involvement 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 senior 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 benefits package, including healthcare, 401k, and ESOP plans.
Biologics Consulting 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.
To learn more about Biologics Consulting Group, Inc. please visit our website at: www.biologicsconsulting.com
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