Job Description
Join MediCure Innovations as a Senior Medical Director and lead transformative healthcare initiatives in a cutting-edge environment. We're seeking a visionary leader to drive clinical excellence, regulatory compliance, and innovation in our expanding portfolio of medical devices. This pivotal role combines strategic oversight with hands-on leadership to shape the future of patient care.
Responsibilities
- Oversee clinical trial designs and execution for medical device innovations
- Ensure compliance with FDA regulations, ISO standards, and GMP protocols
- Lead cross-functional teams including R&D, regulatory affairs, and quality assurance
- Develop strategic medical affairs plans and KPIs for product lifecycle management
- Represent company at medical conferences and engage with key opinion leaders
- Manage post-market surveillance and adverse event reporting systems
- Drive evidence generation through publication strategy and real-world data analysis
Qualifications
- MD/DO with 10+ years of medical device or biotech experience
- Board certification in relevant medical specialty (e.g., Cardiology, Orthopedics)
- Proven track record in FDA submissions and regulatory strategy
- Advanced degree or MBA preferred
- Strong expertise in clinical trial methodology and statistical analysis
- Experience managing medical affairs teams and budgets >$5M
- Demonstrated success in product commercialization and lifecycle management
- Excellent communication skills for stakeholder engagement and public speaking