Sr Director, Medical Safety Officer
- San Diego, CA
- Permanent
- Full-time
- Comprehensive understanding of medical risk evaluation, mitigation strategies, and patient safety principles.
- Expertise in clinical practices, particularly in Breast/GYN or General Surgery.
- Strong knowledge of medical device regulations, compliance standards, and risk management processes.
- Familiarity with basic statistical techniques, epidemiological principles, and data interpretation.
- Awareness of digital medicine and artificial intelligence integration in medical devices.
- Advanced ability to assess product risk-benefit profiles and interpret post-market safety data.
- Proficiency in evaluating adverse events, complaints, and conducting health hazard assessments.
- Effective communication and interpersonal skills for collaboration with cross-functional teams, customers, and regulators.
- Leadership skills to guide audits, regulatory interactions, and field action processes.
- Analytical and critical thinking skills for clinical study design, risk assessments, and safety evaluations.
- Detail-oriented and analytical, with a focus on ensuring patient safety and product performance.
- Collaborative and team-oriented, promoting partnerships across departments and stakeholders.
- Proactive and adaptable, thriving in a dynamic and fast-paced environment.
- Ethical and professional, ensuring compliance with regulatory and legal standards.
- Innovative and forward-thinking, with a commitment to improving healthcare outcomes.
- MD designation or equivalent, with at least 5 years of clinical experience as a Breast/GYN or General Surgeon.
- Experience in risk evaluation, medical devices, or the life sciences industry.
- Proven track record of interfacing with senior leadership in a global healthcare company.
- Clinical study/research experience and familiarity with digital medicine/AI integration are advantageous.