Becker Consulting, Inc. is a leading healthcare consulting firm based in Washington, DC. The company provides complex clinical and regulatory consulting services to healthcare companies, their counsel, and investors. The focus of the work is on FDA regulation and approval of innovative healthcare products, FDA compliance, and post-marketing safety and litigation support.

Our work is conducted with a commitment to excellence, careful execution, and efficient management. We offer creative and challenging work, state-of-the-art resources, opportunities to gain research and consulting skills, and domain expertise in FDA regulation of drugs and medical devices directly from leaders in the field.

This dynamic working environment includes assignments for Becker VSG, our sister company, that focuses on strategic consulting for the financial community and early-stage companies in the medical device space.

The Project Manager, Regulatory Affairs is responsible for independently managing the execution of multiple client assignments, which includes developing FDA strategies and product development guidance to successfully achieve clearance or approval of innovative medical devices. The Project Manager will also manage the client relationship, proposals, project budgets, and management of the project teams. Preparation of regulatory submissions, including 510(k)s, PMAs, IDEs, appeals, and support for FDA Advisory Panels are common work products for this position.

The day to day work is dynamic, with exposure to cutting edge technology, business leaders, and thought leaders in the clinical community.

The position requires at least 5 years of experience in the FDA regulation of medical devices, with a record of successful submissions for innovative products to FDA, and managing teams comprised of the various subject matter experts required for complex assignments.

Responsible for finding, organizing, abstracting, and analyzing scientific, regulatory, and business information to support assignments by the firm for commercial clients. The client work is directed at providing strategic support to the development and FDA approval of new healthcare products, and due diligence evaluations of potential acquisition targets. The job requires attention to detail, the ability to discern critical information, excellent oral and written communication skills, initiative, and the desire to work in a fast-paced, challenging environment.

The Research Associate must have an undergraduate degree in a life science, with a strong quantitative background.

We offer competitive salary and benefits. To apply, submit cover letter with salary expectations, resume, and three references to:

Human Resources
Becker & Associates Consulting, Inc.
2001 Pennsylvania Ave NW, Suite 950
Washington, DC 20006
E-mail: hr@becker-consult.com