VitalConnect

Analyst

• Analyze and review EKG recordings, documenting interpretation findings to clinical accuracy and completeness
• Perform comprehensive EKG annotation including rhythm, beat-level, fiducial marker, and rhythm onset/offset annotation
• Identify and classify advanced cardiac rhythms, arrhythmias, conduction abnormalities, ectopy, pauses, artifact, pacemaker rhythms, and ICD related events
• Maintain strict departmental quality and productivity standards, consistently achieving a performance benchmark of 92% or higher
• Successfully meet all assigned project goals, deliverables, and timelines established by the Manager of Data Annotation
• Support ongoing product development initiatives by providing accurate, clinically sound EKG interpretations
• Collaborate with team members to review and interpret complex or ambiguous EKG recordings, ensuring consensus, clinical accuracy, and annotation consistency
• Demonstrate professionalism, integrity, accountability, and a strong work ethic while operating effectively with minimal supervision
• Maintain strict confidentiality and ensure full compliance with company policies, data security guidelines, and regulatory standards

Senior EKG Analyst

Compliance

• Responsible for regulatory affairs activities such as regulatory submissions, registrations and listings.
• Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards.
• Assist in creation and maintenance of regulatory files.
• Assist with post-market activities.
• Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries.
• Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
• Maintain regulatory files.
• Maintain and update regulatory authorizations, such as 510(k)s, medical device licenses, certificates, and CE Technical Files for EU, etc.
• Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
• Support approval in other regions as required.
• Assist in preparing response to regulatory authorities’ questions within assigned timelines.
• Stay abreast of regulatory procedures and changes in regulatory climate.
• Assess device related incidents/complaints for medical device reporting requirements.
• Compile and submit reportable events to relevant regulatory authorities in timely manner.
• Handle recalls and field actions, if required.
• Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
• Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

Senior EKG Analyst

Regulatory Affairs Director