Medical Director, EP, Medical and Patient Safety
Job Description
Job Description
Position Summary:
This physician leadership role will provide medical expertise and strategic guidance across the lifecycle of electrophysiology and left atrial appendage closure (LAAC) therapies. As the clinical voice of the physician and patient, the Global Medical Director will partner with Clinical Research, Research and Development (R&D), Quality, Regulatory Affairs and Commercial teams to support innovation, clinical evidence generation, product development and patient safety.
Responsibilities:
- Serve as a medical expert and patient advocate for electrophysiology and LAAC therapies throughout the product lifecycle.
- Provide medical leadership and benefit-risk assessment across product development, clinical studies and post-market activities.
- Partner with Clinical Research, Clinical Evidence, Quality, Regulatory Affairs, R&D, Marketing and Business Development teams to support product strategy and medical decision-making.
- Provide medical oversight for clinical trials, including protocol development, investigator engagement, patient safety monitoring, data interpretation and scientific dissemination.
- Support post-market surveillance activities, including safety signal evaluation, device performance assessment and health risk analysis.
- Collaborate with health care providers, investigators and internal teams to assess significant adverse events and emerging clinical concerns.
- Represent the company with key opinion leaders, regulatory authorities, advisory boards and professional societies.
- Review and approve clinical, scientific and regulatory documents, including clinical evidence reports, safety communications and risk management materials.
- Provide medical reviews of scientific, educational and promotional content to ensure clinical accuracy and compliance.
- Contribute clinical expertise to innovation initiatives, product development activities, business development evaluations and due diligence efforts.
- Support training, mentorship and development of medical and cross-functional teams.
Required Qualifications:
- Valid and unrestricted Medical Doctor (MD) degree or accepted international equivalent.
- Board certified or board eligible in Clinical Cardiac Electrophysiology, or equivalent international certification.
- Valid, unrestricted license to practice medicine and in good standing with the applicable licensing authority.
- Minimum 5 years of experience as an independent cardiac electrophysiologist with expertise in complex arrhythmia management and advanced electrophysiology procedures.
- Demonstrated ability to evaluate clinical data, assess benefit-risk profiles and apply sound medical judgment.
- Working knowledge of clinical trial design, Good Clinical Practice (GCP) and medical device development.
Preferred Qualifications:
- Proven experience as a clinical investigator or participation on an Institutional Review Board (IRB), Clinical Events Committee (CEC) or similar oversight body.
- Proven knowledge of global medical device regulations, post-market surveillance and medical safety practices.
- Proven experience supporting innovation, business development or technology assessment activities.
- Global perspective and familiarity with electrophysiology practice across diverse health care systems.
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