Regulatory Scientist, Vascular

Cook Group

. Fulfill premarket and post-market regulatory requirements for medical devices manufactured by Cook Group companies .

Posted 9/23/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory requirements for medical devices, including IDEs, PMAs, and 510(k)s, while effectively communicating technical and scientific information. Proven ability to collaborate with cross-functional teams to develop and implement regulatory strategies and assess new technologies.

Highest-signal resume keywords

Regulatory SubmissionsMedical Device RegulationsTechnical CommunicationStatistical AnalysisProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory RequirementsRegulatory SubmissionsStatistical MethodsTechnical Problem-SolvingScientific ReviewData AnalysisRegulatory GuidanceProject PlanningClinical Evaluation ReportsAI and Data Concepts

Soft Skills

Effective CommunicationTeam CollaborationOrganizational SkillsPrioritization

Tools & Technologies

Microsoft Office

Industry Keywords

Medical DevicesRegulatory ScienceGlobal Regulatory AuthoritiesClinical Strategy DevelopmentChange Requests

About the role

Key responsibilities & impact

Fulfill premarket and post-market regulatory requirements for medical devices manufactured by Cook Group companies
Coordinate with cross-functional teams to develop strategies for new medical devices and support existing devices
Maintain knowledge of medical-device regulations and assess their impact on projects
Learn new technical subjects and communicate technical and scientific information to project teams and regulatory authorities
Coordinate with the Director of Regulatory Science to understand goals and priorities, develop project plans, and facilitate project progress
Assess new technologies for regulatory pathways
Collaborate with Business Units, Engineering, Clinical, and Marketing to develop and implement scientifically sound regulatory strategies
Provide scientific review and regulatory guidance throughout projects, including non-clinical and clinical strategy development
Review non-clinical and clinical data for accuracy, completeness, and submission suitability
Write or coordinate clear regulatory documents and submissions to global regulatory authorities
Provide technical, scientific, and regulatory leadership for new-device approvals and maintenance of marketed-device approvals
Review change requests for supporting-data adequacy and reporting requirements
Travel as necessary to support projects

Requirements

What you’ll need

Master's degree or PhD in a scientific or an engineering discipline, or 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
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, organize, and prioritize within time constraints
Familiarity with Microsoft Office software
Commitment to participate in a team-based environment
Fluency in Artificial Intelligence (AI) and data concepts, including critically evaluating AI outputs, improving workflows using approved tools, identifying and mitigating bias or inaccuracies, and communicating AI-driven insights clearly and responsibly
Legally authorized to be employed in the United States
No employment visa sponsorship provided

Benefits

Comp & perks

Fully remote positions are available
Option to work at the West Lafayette, IN or Bloomington, IN Cook facilities
Equal employment opportunity employer