Medical Safety Officer - Electrophysiology

Role Summary

The Medical Safety Officer (MSO) provides medical safety stewardship for Medical Device products, serving as a medically independent voice while collaborating with Quality, Regulatory, Clinical, Medical Affairs, Epidemiology, and Safety sciences. The MSO executes the Medical Safety Organization’s strategy, leading programs in priority areas defined by the Chief Medical Officer, and acts as a subject-matter authority in risk management across the product lifecycle, with primary responsibility for Electrophysiology, Cardiac Imaging, Structural Heart, and Reprocessing.

Responsibilities

• Assess product risk-benefit and provide medical input on Risk Management Reports, Health Hazards Evaluations, Clinical Evaluation Reports, Product Safety Surveillance Plans, and related materials; review mitigations, labeling, and safety training content; manage adverse events, complaints, and communications.
• Clinically interpret post-marketing safety data, aggregated complaints, individual case safety reports, and literature with potential safety data.
• Contribute to the design and interpretation of safety-related studies and SSP activities.
• Represent Medical Safety in product reviews during development; evaluate medical impact of manufacturing and design issues; oversee and guide product safety performance.
• Monitor external sources/trends for emerging issues (e.g., MDR/MDV trends, regulatory/market intelligence, literature).
• Advise on failure investigations and provide medical opinion on reportability; gather additional medical information from customers/users as needed.
• Review safety information provided to customers to prevent repeat adverse events; discuss adverse events with healthcare professionals when requested.
• Act as the medical representative in review processes for field actions and evaluate effectiveness of field safety corrective actions.
• Ensure consistency in medical evaluations, Quality Review Board decisions, and overall safety evaluations; deploy standard practices in coordination with the MD Chief Medical Officer.
• Use appropriate metrics to assess patient safety processes; contribute to and review product harm/hazards definitions and reportability criteria.
• Serve as a subject-matter expert in audits and regulatory interactions; review and approve medical-safety-related reports and filings; respond to regulatory bodies, clinicians, and patients as needed.
• Coordinate with Regional Safety Officers to ensure timely information sharing.

Qualifications

Required:
• Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree
• Minimum of 3 years clinical or research experience
• Relevant experience or specific training in Cardiovascular field
• Ability to use common computer programs (Microsoft Office Outlook, Word, Excel, PowerPoint)
• Knowledge of basic statistical techniques and epidemiological principles
• Knowledge of pre-clinical or clinical research basic concepts

Preferred:
• Specialties: Electrophysiology, Interventional Cardiology, Cardiology, Interventional Radiology
• Experience in risk evaluation and mitigation
• Medical device and/or pharmaceutical industry experience in healthcare or device industry
• Clinical study/research experience
• Experience working with senior leadership within a global healthcare company
• Advanced statistical knowledge (e.g., multivariate data analysis)
• Knowledge of local and international Medical Device regulations

Skills

• Clinical Operations
• Compliance Management
• Consulting
• Design Mindset
• Developing Others
• Leadership
• Medicines and Device Development and Regulation
• Operational Excellence
• Quality Control (QC)
• Research Ethics
• Risk Compliance
• Risk Management
• Safety Investigations
• Safety-Oriented
• Serious Adverse Event Reporting
• Standard Operating Procedure (SOP)
• Succession Planning
• Surveillance