Regulatory Scientist/Specialist

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 Scientists/Specialists for its growing Regulatory Submissions 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 brining 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.

  • 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;
  • Write and/or direct the preparation of clear and effective regulatory submissions.

Requirements / Qualifications

  • Ph.D. in a science or engineering field or M.S. in science or engineering with equivalent industry regulatory experience;
  • Experience in leading and/or organizing a project team in the approval process of medical devices from either an industry or regulatory authority viewpoint is highly desirable;
  • Familiarity with the components of regulatory submissions, particularly IDEs, PMAs, and 510(k)s; experience with INDs and NDAs desirable;
  • Basic understanding of statistical methods and analysis;
  • 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 submit your resume to HR@medinst.com.  We accept Word documents and PDFs.