Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.
About the role
- Regulatory Scientist responsible for utilizing scientific knowledge for medical device regulatory compliance at Cook Research. Coordinating with cross-functional teams to develop regulatory strategy for new medical devices.
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
- Assess new 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/or maintaining existing approvals for marketed devices
- Assist in 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.
Requirements
- 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.
Benefits
- 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 inaccuracies, and communicate AI driven insights clearly and responsibly to peers and managers.
Job title
Job type
Experience level
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Not specified
Degree requirement
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