Requisition ID 2020-7351 Job Location(s) West Lafayette IN United States Travel Less than 10% Position Type Full Time Company Med Institute Inc. Category Regulatory Affairs
MED Institute is a Cook Group company that supports researchers, medical device companies, manufacturers, and consultants through the key phases of product development, between the start of an idea and making a product available to clinicians and patients. With more than 30 years of experience in medical device testing, data analysis, and global regulatory submission preparation, our team knows what it takes to guide a product through all the complex steps required for market.
This function will provide senior leadership and scientific expertise to regulatory projects and will organize and direct regulatory efforts through any phase of a project.
Essential Job Function/Duties:
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.
Ensure compliance with regulations and applicable standards.
Assure that the conduct and documentation of the project adhere to procedure.
Minimum Work Experience/Educational Requirements:
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.
Sign non-competition and confidentiality agreements.
Compliance with all policies of the company including without limitation the MED Institute Employee Manual, COOK Global Code of Coduct, COOK Electronic Information Policy, HIPAA regulations, and COOK Policy and Guidance on Interation with Healthcare Professionals.
This job description in no way states or implies that these are the only duties to be performed. This position is expected to follow other job related instructions and duties.
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