Regulatory Scientist

3 weeks ago
Requisition ID
2017-3270
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Research Inc.
Category
Regulatory Affairs

Overview

Cook Research Incorporated is currently accepting applications for a Regulatory Scientist to become a part of our growing Regulatory team.  The Regulatory Scientist at Cook Research Incorporated will use regulatory skills and scientific knowledge to fulfill premarket and postmarket regulatory requirements for medical devices manufactured by the Cook Group companies.

Responsibilities

• Understand regulations and impact on projects

• Provide critical scientific review and regulatory-based guidance through all phases of a project, provide direction in the development of non-clinical study plans to support global regulatory strategy and submissions, provide direction in the development of a clinical study design, and review clinical study protocols and other clinical study documentation, and provide critical review of non-clinical reports and clinical study reports for accuracy and consistency with regulator’s expectations

• Write, and/or coordinate the preparation of clear and effective documents, including submissions to global regulatory authorities

• Collaborate and interact effectively with other Cook companies and global functions (e.g., Clinical, Quality, Marketing) within Cook to develop and implement a scientifically sound regulatory strategy for a project team

• Provide direction and leadership from a technical and regulatory point of view to a project team pursuing approval of a new product

• Assist in the review of change requests for adequacy of supporting data and to determine necessity of reporting to regulatory authorities

• Travel, as necessary, to support projects

Qualifications

• Master's degree or PhD in a scientific or an engineering discipline or have equivalent medical device industry/regulatory experience

• Familiarity with applicable regulatory requirements and regulatory submissions (including IDEs, PMAs, 510(k)s, Clinical Evaluation Reports, and other global regulatory documents) is beneficial

• Excellent technical and problem-solving skills

• Ability to effectively communicate in both spoken and written form

• Familiarity with statistical methods, analysis, and interpretation

• Ability to work on multiple projects (i.e., multi-task), organize, and prioritize within time constraints

• Familiarity with Microsoft Office software

• Commit to participate in a team-based environment

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