MedTech Clinical Safety Manager

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, with the ability to present information clearly to internal and external stakeholders.

• 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.

• Manage day-to-day execution of assigned client safety projects across medical device clinical studies and post-market safety activities, with oversight from senior Clinical Safety leadership.

• Develop and maintain project plans, timelines, deliverables, documentation requirements, meeting schedules, and action-item trackers for assigned safety projects and committee activities; 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 meetings, preparing and distributing meeting materials, coordinating with committee members and internal/external stakeholders, facilitating meeting logistics, documenting meeting outcomes and decisions, and tracking action items through completion.

• 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 for internal and client-facing discussions.

• 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 under the guidance of senior Clinical Safety staff.

• Collaborate with Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, finance/resource partners, and project teams to coordinate resources, maintain delivery commitments, and support timely resolution of safety-related activities.

• 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 routine operational issues and recommend practical improvements to enhance efficiency, client satisfaction, and compliance.

• 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, averaging approximately one meeting per week. Flexible scheduling may be used to accommodate these requirements.

• Perform other duties and projects as assigned.