What are the responsibilities and job description for the Senior Regulatory & Clinical Strategy Consultant position at Wellesley Cove Group?
Company Description
Wellesley Cove Group (WCG) is a boutique consulting firm that helps clients plan and execute organizational shifts in various areas including general business practices, strategic innovation efforts, technology, and data analysis initiatives.
Role Description
This is a full-time role for a Senior Regulatory & Clinical Strategy Consultant. The consultant will be responsible for day-to-day tasks related to regulatory and clinical strategy consulting, working closely with clients to plan and execute shifts in their operations.
Qualifications
- Proven Expertise in regulatory affairs and clinical research for medical devices, including AI / ML-based solutions.
- Demonstrated Success with FDA submissions (e.g., 510(k), De Novo) and knowledge of U.S. healthcare compliance.
- Strong Analytical & Communication Skills for translating complex regulatory concepts into actionable insights.
- Experience in Partner Management, working effectively with CROs, legal teams, and clinical stakeholders.
- Big-4 management consulting experience required.
- Knowledge of regulatory and clinical practices in the healthcare industry
- Bachelor's or Master's degree in a related field
