Regulatory Scientist, Vascular

Job not on LinkedIn

🔥 15 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 13%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cook Group

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Cook Group is a family of ethical and entrepreneurial companies with roots in medical devices and a commitment to empowering people and communities. Headquartered in Indiana and with a global footprint, Cook Group operates in various sectors, including life sciences, property management, and resort and service businesses. The company's mission is driven by values of integrity, quality, respect, and transparency, focusing on innovative solutions that meet the needs of employees, customers, and communities.

📋 Description

• 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

• 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

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