Join our team in Mounds View, MN, a vibrant location that offers a great work-life balance and a collaborative work environment. We are seeking a skilled professional to take on a pivotal role in our clinical evaluation team.
Key Responsibilities
- Analyze and integrate diverse clinical evidence to evaluate product safety and performance, identifying potential data gaps or risks.
- Lead and support clinical evaluations in compliance with applicable global regulatory requirements.
- Collaborate with cross-functional stakeholders to define clinical evaluation strategies and support regulatory interactions.
- Maintain current knowledge of clinical evaluation best practices and the evolving clinical and regulatory landscape.
- Produce clear, accurate, and high-quality clinical documentation.
- Support risk/benefit and state-of-the-art assessments, manage document timelines, address regulatory feedback, a...