MedTech Clinical Safety Manager

Job Summary

The MedTech Clinical Safety Manager is a client-facing role that coordinates the delivery of assigned medical device and combination product safety projects across clinical and post-market programs. Working with guidance from senior Clinical Safety leadership, this role manages day-to-day project execution, including timelines, deliverables, safety review committee activities, documentation, client communications, and cross-functional follow-up.

Job Responsibilities

• Manage day-to-day execution of assigned client safety projects across medical device clinical studies and post-market safety activities.
• Develop and maintain project plans, timelines, deliverables, documentation requirements, meeting schedules, and action-item trackers; proactively escalate risks, scope changes, resource needs, or potential delays.
• Lead and coordinate Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) meetings, including scheduling, preparing materials, coordinating stakeholders, documenting outcomes, and tracking action items.
• Collect, review, organize, and maintain safety documentation, including adverse event reports, product complaints, committee records, and safety tracking logs.
• Support case intake, data entry, reconciliation, quality checks, and maintenance of safety records in accordance with internal procedures and regulatory requirements.
• Prepare and maintain project status reports, utilization and delivery metrics, meeting materials, and presentations.
• Serve as a day-to-day contact for assigned project activities, participate in client meetings, communicate status and next steps, and support resolution of delivery issues.
• Collaborate with Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, finance/resource partners, and project teams to coordinate resources and maintain delivery commitments.
• Support inspection and audit readiness by maintaining complete, accurate, and organized documentation and safety records.
• Contribute to the implementation and refinement of safety processes, workflows, templates, and standard operating procedures.
• Monitor project performance against scope, timelines, and quality expectations; identify operational issues and recommend improvements.
• Maintain working knowledge of applicable FDA requirements, EU MDR, ISO 14155, medical device vigilance, and post-market surveillance requirements.
• Participate in occasional early morning or evening meetings to support global teams and safety review committees.

Required Qualifications

• Bachelor's degree in Nursing, Life Sciences, Health Sciences, Public Health, Biology, Biomedical Sciences, or a related field.
• Minimum of 4 years of experience in clinical research, medical device safety, project coordination or management, healthcare, quality, regulatory affairs, or a related field.
• Experience supporting CECs, DSMBs, or other independent safety review committees.
• Experience coordinating client-facing projects, timelines, deliverables, meetings, and operational activities across multiple stakeholders.
• Strong organizational and prioritization skills, with the ability to manage multiple assignments and deadlines.
• Excellent verbal and written communication skills.
• Demonstrated attention to detail and ability to maintain accurate, inspection-ready documentation.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook.
• Ability to work effectively both independently and as part of a fast-paced, collaborative team.

Preferred Qualifications

• Experience supporting medical device clinical trials, clinical safety, complaint handling, quality, or regulatory activities.
• Familiarity with safety databases, clinical trial management systems (CTMS), electronic Trial Master Files (eTMF), or medical device complaint handling systems.
• Familiarity with adverse event reporting, medical device vigilance, post-market surveillance, or product complaint processes.
• Working knowledge of Good Clinical Practice (GCP), FDA medical device regulations, ISO 14155, EU MDR, or related requirements.
• Experience preparing project metrics, status reports, meeting documentation, or client-facing materials.
• Experience working in a billable consulting, CRO, or professional-services environment.