Note: The job is a remote job and is open to candidates in USA. Kardium Inc. is a company dedicated to improving the lives of patients with atrial fibrillation through innovative medical devices. They are seeking a Director of Clinical Affairs to lead global clinical studies in electrophysiology and catheter ablation, ensuring alignment with product strategy and regulatory pathways.
Responsibilities
- Lead the strategic design and execution of clinical studies (feasibility, pivotal, post-market) for catheter ablation devices and therapies
- Serve as the clinical subject matter expert for electrophysiology, ensuring scientific rigor and clinical relevance across all programs
- Collaborate with R&D, regulatory, marketing, and medical affairs teams to align clinical objectives with business goals
- Develop relationships with global KOLs, investigators, and institutions to support study recruitment and protocol development
- Oversee CROs, clinical sites, and internal teams to ensure adherence to timelines, budgets, and regulatory compliance (GCP, FDA, EU MDR)
- Support regulatory submissions (IDE, PMA, CE Mark) and interface with regulatory agencies as needed
- Analyze clinical data and provide strategic input on interpretation, reporting, and publication efforts
Skills
- Advanced degree (MD, PhD, or equivalent) preferred; Master's in a related field with extensive experience will be considered
- Minimum 8–10 years of clinical affairs experience in the medical device industry, with a strong emphasis on electrophysiology and catheter ablation
- Demonstrated leadership in planning and executing complex, multi-center clinical trials
- Proven track record of successful regulatory interactions and submissions (FDA, EMA, etc.)
- Deep understanding of electrophysiology clinical workflows, unmet needs, and physician decision-making
- Exceptional communication, leadership, and cross-functional collaboration skills
- Willingness to travel domestically and internationally (up to 20%)
- Clinical background in cardiology or electrophysiology preferred (e.g., former EP clinician or clinical specialist)
Benefits
- 5% 401k contribution
- Participate in Kardium’s stock option plan
- Base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals
- Comprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting period
- Work-day flexibility – additionally, we provide 3 personal days per year
- Support – for you (and your dependents) overall well-being
- Career progression and learning support
- Professional membership support
Company Overview
Kardium has developed the Globe System - a revolutionary medical device for the diagnosis and treatment of atrial fibrillation. . It was founded in 2007, and is headquartered in Burnaby, British Columbia, CAN, with a workforce of 501-1000 employees. Its website is http://kardium.com.