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Regulatory Scientist
MED Institute, Inc.
West Lafayette

Date:  8/9/2010
Position Type:  Full Time

Start Date:  Immediate Availability

Duties/Responsibilities:

MED Institute seeks experienced Regulatory Scientists for its growing Regulatory group.  Acting as an in-house consultant for MED Institute and other Cook Group companies, this position will allow you to use your regulatory skills and scientific knowledge in bringing innovative technologies to market.  Scientific insight and fundamental understanding of basic regulatory processes are as essential as skills in a specific area.  Opportunities, responsibilities and compensation will be commensurate with background, skills and experience.

Responsibilities

• The qualified candidate must demonstrate the ability to provide organization, direction, and leadership from a regulatory point of view to a project team pursuing approval of new medical devices. This regulatory-based guidance will begin in the research and development process, continue through pre-clinical and clinical testing and final data analysis, and include preparation of regulatory submissions.
• Write and direct the preparation of clear and effective regulatory submissions.

Requirements/Qualifications:

• Two or more years experience in the approval process of medical devices from either an industry or regulatory authority viewpoint is advantageous.
• Graduate research in biomedical engineering and/or coursework in medical device regulatory affairs is also advantageous.
• Experience organizing and preparing successful regulatory submissions (in particular, IDEs, PMAs, 510(k)s, INDs or NDAs) is important.
• A basic understanding of statistical methods and analysis is needed.
• The ability to communicate clearly and concisely in both spoken and written form is essential.
• The ability and commitment to operate in a team-based environment and good interpersonal skills are essential.

Experience Required:  2+ years

Company Description:
MED Institute was incorporated in 1983 to identify and develop new medical product concepts. From conception to marketing, MED provides a continuum of services to support the medical product manufacturer. The staff includes over 180 engineers, scientists, clinical specialists, physicians, nurses, and technical personnel. MED provides a dynamic and challenging work environment found to be especially rewarding to those with initiative.

Other:

Benefits include 401k and profit sharing plans, health, dental, life and optical insurance, eight paid holidays per year, and vacation.

MED Institute is an Equal Opportunity Employer (EOE).

Application Instructions:

Please e-mail resume to hr@medinst.com