Overview
The Regulatory Scientistis responsible forutilizingtheir 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 developstrategyfor 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
- Maintainknowledge of regulations applicable to submissions for medical devices and understand their impact on projects
- Must be able to rapidly learn new technicalsubjects 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 todeterminenecessity 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.
