Medical Director, Medical Device, Patient Safety

Role Summary

Medical Device Safety Physician leads the safety oversight relevant to assigned products to determine and advise actions to meet safety goals. Collaborates with cross-functional teams to identify, evaluate, and communicate safety issues. Responsible for proactive safety strategy, safety assessments, and lifecycle safety risk management for medical devices, clinical studies, and marketed products.

Responsibilities

• Device, Combination Products, and InVitro Diagnostics, Clinical Trials- Medical assessment and Management
• Draft and/or review Safety Management Plan and safety sections of key trial documents (informed consent, protocols, AE management, AEs of interest)
• Evaluate safety data from clinical trials on a contemporaneous basis
• Provide medical leadership on global teams on safety-related issues
• Oversee safety of subjects in clinical trials and development programs
• Perform medical assessment of Serious Adverse Events (SAEs) including causality and events of interest
• Provide safety input to Global Product Teams regarding causality and data reconciliation
• Review and approve SAE/AEs listings and related safety data
• Respond to safety questions from investigator sites and IRBs
• Interpret safety findings for clinical study reports and manage safety coding for projects
• Contribute to integrated safety summaries, risk/benefit assessments, and regulatory submissions
• Ensure CSR data is accurate and meaningful
• Liaise with Data Safety Monitoring Boards
• Respond to safety questions from investigator sites and IRBs

Post-market/Product Surveillance Safety

• Assess product complaints requiring medical interpretation
• Document medical assessments prior to MDR submissions to regulatory authorities
• Provide medical input to product surveillance and safety reports for regulatory authorities
• Support reportability decisions and accurate coding for device adverse events and malfunctions

Risk Management & Regulatory Support

• Assess newly identified risks for risk management plans and minimization activities
• Develop and review CHL and aFMEAs for assigned products
• Review risk management documents (AE Matrix, Risk Management Plans, Risk Benefit Analysis, FMEAs, and Reports)
• Participate in Health Product Hazard Assessments and Health Hazard Evaluations
• Contribute to safety responses to regulatory authorities
• Review literature to support new device applications

Review Safety Data Information for Instructions for Use (IFU) to ensure accurate device labeling

New Product Development

Participates as a Core Team Member on New Product Development projects as assigned

SOP Development & Training, Personnel Development

• Mentor colleagues in clinical safety management and provide technical knowledge to Device Safety Analysts
• Maintain knowledge of indications, labeling, pharmacology, regulations, and SOPs
• Assist in developing and updating clinical safety documents and Device SOPs

Qualifications

• MD / DO with 2+ years of residency with patient management experience required
• Prior device safety experience preferred
• Ability to analyze clinical, post-market, and epidemiological data
• Strong technical writing skills
• Collaborative team player with ability to work independently
• Effective presentation skills in group settings
• Fluency in English (written and oral)