Senior Medical Device Vigilance Specialist

🏗 We're Hiring: Senior Medical Device Vigilance Specialist

📍 Location: United Arab Emirates (Remote)

🕒 Employment Type: Full-Time

💼 Experience Level: Mid-Level to Senior

🌐 Work Arrangement: Fully Remote

About Us

We are a construction-focused organization committed to delivering complex projects through disciplined contract management, operational excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of safety, compliance, quality, and business performance. We value accountability, continuous improvement, and effective risk management across all business functions, including specialized healthcare, medical technology, and regulatory support activities.

The Role

We are seeking an experienced Senior Medical Device Vigilance Specialist to oversee medical device safety surveillance, adverse event reporting, incident assessment, regulatory compliance, post-market surveillance, and risk management activities. The successful candidate will support the identification, evaluation, documentation, and reporting of medical device incidents and potential safety concerns in accordance with applicable regulatory requirements and organizational quality management procedures.

This role requires strong knowledge of medical device vigilance, post-market monitoring, regulatory reporting timelines, complaint handling, risk assessment, and corrective and preventive actions. The ideal candidate will collaborate with Quality Assurance, Regulatory Affairs, Clinical, Medical Affairs, Manufacturing, Customer Support, and external regulatory stakeholders to protect patient safety, maintain product compliance, and support continuous improvement throughout the medical device lifecycle.

Key Responsibilities

• Lead and coordinate medical device vigilance activities across applicable product portfolios and markets.
• Oversee the identification, assessment, investigation, and reporting of medical device incidents and potential safety issues.
• Review incoming complaints, adverse event notifications, product malfunction reports, and other safety-related information.
• Determine whether reported events meet applicable definitions of serious incidents, adverse events, or reportable malfunctions.
• Assess the potential impact of medical device incidents on patients, users, healthcare professionals, and other affected parties.
• Evaluate incident severity, probability of recurrence, clinical consequences, and potential public health implications.
• Ensure reportable incidents are submitted to the relevant regulatory authorities within applicable statutory deadlines.
• Prepare, review, and coordinate initial, follow-up, and final vigilance reports.
• Maintain accurate records of incident assessments, reporting decisions, regulatory submissions, and supporting evidence.
• Monitor vigilance reporting requirements across relevant jurisdictions, including applicable United Arab Emirates requirements and other assigned markets.
• Interpret and apply relevant medical device regulations, vigilance guidance, and post-market surveillance requirements.
• Maintain awareness of applicable international medical device regulatory frameworks and reporting standards.
• Support compliance with relevant requirements under the EU Medical Device Regulation, where applicable.
• Support compliance with applicable United States Food and Drug Administration medical device reporting requirements, where relevant.
• Apply relevant ISO standards and recognized industry practices governing medical device quality, risk management, and post-market surveillance.
• Monitor regulatory updates affecting adverse event reporting, field safety corrective actions, and post-market safety obligations.
• Translate regulatory changes into practical updates to internal vigilance procedures, work instructions, and reporting processes.
• Establish and maintain standardized procedures for medical device incident intake, triage, assessment, investigation, escalation, and closure.
• Review complaints to determine whether additional medical, technical, clinical, or manufacturing investigations are required.
• Coordinate investigations involving device failures, performance deviations, labeling issues, usability concerns, and suspected design or manufacturing defects.
• Collaborate with engineering and technical teams to evaluate the underlying causes of device malfunctions.
• Assess whether reported events may be attributable to product design, manufacturing processes, software behavior, packaging, storage, transportation, or user interaction.
• Evaluate incidents involving medical device software, connected devices, digital health technologies, and cybersecurity-related safety concerns, where applicable.
• Review available clinical information, device history records, product specifications, service reports, and relevant technical documentation.
• Ensure incident investigations are objective, evidence-based, adequately documented, and completed within established timelines.
• Coordinate with clinical and medical experts when specialized assessment of patient harm or clinical outcomes is required.
• Evaluate whether additional information should be requested from complainants, healthcare professionals, distributors, or other reporting parties.
• Ensure follow-up activities are documented and outstanding information requests are appropriately tracked.
• Maintain clear communication with relevant internal teams throughout incident assessment and investigation.
• Identify trends involving repeated complaints, similar device failures, unexpected performance issues, or emerging safety signals.
• Conduct periodic reviews of complaint and vigilance data to identify potential product safety trends.
• Apply appropriate statistical and qualitative methods to support signal detection and trend analysis.
• Investigate increases in incident frequency, severity, or recurrence that may indicate a developing product risk.
• Prepare trend reports and safety summaries for Quality Assurance, Regulatory Affairs, Medical Affairs, and senior management.
• Escalate significant safety signals and emerging risks through established governance and decision-making channels.
• Support the development, maintenance, and periodic review of post-market surveillance plans.
• Contribute to post-market surveillance reports, periodic safety update reports, and other applicable product safety deliverables.
• Support the preparation and maintenance of Periodic Safety Update Reports (PSURs), where required.
• Contribute to post-market clinical follow-up activities and the assessment of real-world device performance.
• Coordinate the collection and evaluation of post-market information from complaints, clinical feedback, scientific literature, registries, distributors, and other relevant sources.
• Ensure vigilance findings are appropriately incorporated into post-market surveillance documentation.
• Support the review and updating of product risk management files based on newly identified safety information.
• Collaborate with risk management teams to evaluate whether existing risk controls remain adequate.
• Assist with updates to failure mode and effects analysis, hazard analyses, and related risk assessment documentation.
• Evaluate the residual risk associated with identified incidents and recommend additional mitigation measures when necessary.
• Support decisions regarding product corrections, preventive measures, safety communications, recalls, and field safety corrective actions.
• Coordinate the preparation and review of Field Safety Notices and other safety communications, where applicable.
• Ensure safety communications are accurate, clear, appropriately approved, and distributed to relevant stakeholders.
• Monitor the implementation and effectiveness of field safety corrective actions.
• Maintain traceability between reported incidents, risk assessments, corrective actions, regulatory notifications, and product changes.
• Coordinate with product quality and manufacturing teams on corrective and preventive action (CAPA) investigations.
• Review CAPA plans to ensure that identified root causes and product safety risks are adequately addressed.
• Monitor corrective action implementation, effectiveness checks, and overdue remediation activities.
• Identify recurring quality issues and recommend measures to prevent similar incidents.
• Ensure vigilance investigations are appropriately linked to nonconformities, deviations, change controls, and other quality management records.
• Support product recall assessments and coordination activities when a potential safety issue warrants further action.
• Maintain accurate records of affected products, serial numbers, lot numbers, distribution details, and relevant traceability information.
• Coordinate with Supply Chain, Distribution, Customer Support, and Commercial teams to identify affected products and relevant customers.
• Support reconciliation of distributed products, returned devices, replacement units, and other information required for safety action tracking.
• Ensure relevant product identification and traceability data are available for incident investigations and regulatory submissions.
• Collaborate with Regulatory Affairs to confirm reporting obligations, submission formats, authority requirements, and follow-up expectations.
• Coordinate vigilance activities with authorized representatives, importers, distributors, and other economic operators, as applicable.
• Maintain appropriate communication records with regulatory authorities and external reporting parties.
• Support responses to regulatory authority inquiries, requests for additional information, and follow-up questions.
• Ensure commitments made to regulatory authorities are assigned, monitored, and completed within agreed timelines.