Senior Director, Regulatory Science at Cook Advanced Technologies in West Lafayette, Indiana

Job Description:

Senior Director, Regulatory Science

Posting Date 1 month ago (7/13/2022 10:45 PM)

Requisition ID 2022-11143 Job Location(s) West Lafayette IN United States Travel Less than 10% Position Type Full Time Company Cook Advanced Technologies Category Regulatory Affairs

Overview

This position will provide executive leadership and scientific expertise to regulatory projects and will organize and direct regulatory efforts through any phase of a project.

Responsibilities

• 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 leadership and mentoring for technical personnel


• Direct and conduct the preparation of well-organized regulatory submissions


• Write elements of submissions, as necessary


• Understand and accept customer requests with an "I can help you" attitude


• Maintain excellent relationships with all other service areas; keeping them up to date on regulatory projects and watching for project opportunities for other services areas


• Ensure utmost integrity and compliance with regulations and applicable standards


• Assure that the conduct and documentation of the project adhere to procedure

Qualifications

• Ph.D. in science or engineering or equivalent industry experience


• Minimum of ten 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 (or five years of experience with Cook)


• Familiarity with the components of regulatory submissions, particularly IDEs, PMAs, 510(k)s, INDs, and NDAs


• 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


• Ability to travel as needed; for interactions with regulators and clients


• Current U.S. work authorization and proof of FDA authorized COVID19 vaccination are required for this position at this time.


• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Options

Apply for this job online Apply

Share

Share the job posting with a friend Refer

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Share on your newsfeed

"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.