Regulatory Scientist, Vascular

This is a fully remote position, open to applicants in United States.

📋 Description

• Meet premarket and post-market regulatory obligations for medical devices produced by Cook Group companies.

• Collaborate with cross-functional teams to create strategies for new medical devices and provide support for existing products.

• Keep abreast of medical device regulations and evaluate their implications on projects.

• Acquire knowledge of new technical subjects and convey technical and scientific information to project teams and regulatory bodies.

• Work alongside the Director of Regulatory Science to comprehend goals and priorities, formulate project plans, and ensure project advancement.

• Evaluate new technologies for potential regulatory pathways.

• Partner with Business Units, Engineering, Clinical, and Marketing to devise and execute scientifically valid regulatory strategies.

• Offer scientific review and regulatory advice throughout all project phases, including the development of non-clinical and clinical strategies.

• Assess non-clinical and clinical data for precision, thoroughness, and suitability for submission.

• Draft or coordinate the creation of clear regulatory documents and submissions to international regulatory authorities.

• Provide technical, scientific, and regulatory guidance for approvals of new devices and the maintenance of existing device approvals.

• Evaluate change requests for the adequacy of supporting data and compliance with reporting requirements.

• Travel as needed to support projects.

⛳️ Requirements

• Master’s degree or PhD in a scientific or engineering discipline, or equivalent experience in the medical device industry/regulatory field.

• Knowledge of relevant regulatory requirements and submission processes, including IDEs, PMAs, 510(k)s, Clinical Evaluation Reports, and other international regulatory documents.

• Strong technical and problem-solving abilities.

• Proficient in verbal and written communication.

• Understanding of statistical methods, analysis, and interpretation.

• Capable of managing multiple projects, organizing tasks, and prioritizing under time constraints.

• Familiarity with Microsoft Office applications.

• Dedicated to participating in a team-oriented environment.

• Proficient in Artificial Intelligence (AI) and data concepts, including the critical evaluation of AI outputs, enhancing workflows using approved tools, identifying and mitigating biases or inaccuracies, and clearly and responsibly communicating AI-driven insights.

• Legally authorized to work in the United States.

• Employment visa sponsorship is not available.

🏝️ Benefits

• Fully remote positions are available.

• Option to work at the Cook facilities located in West Lafayette, IN or Bloomington, IN.

• Equal employment opportunity employer.