Job Description

Why Join Us

Join a highly engaged, globally connected team of regulatory experts who play a critical role in bringing life-changing medical devices to physicians and patients around the world. As part of our Regulatory Affairs function, you'll collaborate cross-functionally across the entire product life cycle. With a presence in nearly every Cook location globally — including manufacturing entities, regional offices, and divisions — you'll be part of a team that is at the heart of Cook Medical's mission to deliver innovative solutions to those who need them most.

Overview

The Regulatory Scientist is responsible for utilizing their scientific knowledge and regulatory acumen to fulfill premarket and post-market regulatory requirements for medical devices manufactured by the Cook Group companies.  The Regulatory Scientist will coordinate with cross-functional teams to develop strategy for new medical devices and to support existing devices.  Fully remote positions are available; however, the candidate is welcome to also work at the West Lafayette, IN or Bloomington, IN Cook facilities, if desired.

Responsibilities

• Maintain knowledge of regulations applicable to submissions for medical devices and understand their impact on projects
• Must be able to rapidly learn new technical subjects and communicate technical and scientific information to project teams and regulatory authorities
• Communicate regularly with the Director of Regulatory Science to understand goals/priorities, to develop project plans, and to facilitate project progress
• Assessnew technologies for regulatory pathways
• Collaborate and interact effectively with cross functional teams (e.g., Business Units, Engineering, Clinical, Marketing) to develop and implement a scientifically sound regulatory strategy for a project team in-line with project timelines
• Provide critical scientific review and regulatory-based guidance through all phases of a project; provide direction in non-clinical and clinical strategy development and review non-clinical and clinical data for accuracy, completeness, and suitability for submission to regulatory authorities
• Write, and/or coordinate the preparation of clear and effective documents, including submissions to global regulatory authorities
• Provide direction and leadership from a technical, scientific, and regulatory point of view to project teams pursuing approval of new devices and/ormaintainingexisting approvals for marketed devices
• Assistin the review of change requests for adequacy of supporting data and to determine necessity of reporting to regulatory authorities
• Travel, as necessary, to support projects

Qualifications

Master's degree or PhD in a scientific or an engineering discipline or have 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) is beneficial
• 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 (i.e., multi-task), organize, and prioritize within time constraints
• Familiarity with Microsoft Office software
• Commit to participate in a team-based environment
• This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccurracies, and communicate AI driven insights clearly and responsibly to peers and managers
• 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.