Regulatory & Scientific Communications Scientist

Posted November 30, 2011
Business MED Institute, Inc.
Purdue Research Park of West Lafayette,
n/a
Position Type Full Time
Start Date Immediate Availability

Duties / Responsibilities

MED Institute seeks experienced Regulatory and Scientific Communications Scientists. 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 a deep understanding of regulatory processes are essential skills to succeed in this position.  The ability to effectively author scientific publications, medical presentations, and to provide written regulatory support are also essential.  Opportunities, responsibilities and compensation will be commensurate with background, skills and experience.

  • Provide organization, direction, and leadership from a regulatory point of view to a project team pursuing approval of new medical devices;
  • Provide regulatory-based guidance through all phases of a project: research and development, pre-clinical and clinical testing, and final data analysis and preparation of regulatory submissions;
  • Provide interpretation and analysis of scientific data pertinent to scientific communications projects;
  • Fulfill responsibilities of authorship for scientific communications projects, when appropriate.

 

Requirements / Qualifications

  • M.D. or Ph.D. in a scientific or engineering discipline or equivalent experience;
  • Experience in statistical methods, analysis and interpretation
  • Minimum of two years of experience in leading and/or organizing a project team in the approval process of medical devices from either an industry or regulatory authority viewpoint; 
  • Familiarity with the components of regulatory submissions, particularly IDEs, PMAs, 510(k)s, INDs, and NDAs;
  • Experience with literature searches, manuscript and research paper preparation;
  • Ability to communicate clearly and concisely in both spoken and written form;
  • Ability and commitment to operate in a team-based environment.

 

Company Description

MED Institute, Inc. was established as a resource for Cook Group companies to identify and develop new medical product concepts. This includes new product discovery, prototype development, nonclinical testing, clinical study management and data analysis, education for the medical community, and preparation of regulatory submissions. MED Institute employs a staff of research, medical, engineering, and administrative professionals.

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.

We accept Word documents and PDF's.