Senior Medical Device Risk File Specialist

Job Title: Senior Medical Device Risk File Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior

About the Role

We are seeking an experienced Senior Medical Device Risk File Specialist to lead remote risk management documentation, technical evidence assessment, and quality oversight throughout the medical device lifecycle. The role focuses on maintaining risk management files, evaluating hazards, reviewing failure mode and effects analyses (FMEA), assessing risk controls, and ensuring traceability between identified risks, verification evidence, and product requirements.

The successful candidate will collaborate with engineering, research and development, clinical affairs, regulatory affairs, quality assurance, and manufacturing teams. This is a fully remote technical documentation and risk analysis position. Physical device testing, laboratory evaluations, manufacturing inspections, clinical assessments, and on-site investigations must be performed by qualified local personnel.

Key Responsibilities

• Develop, maintain, and review medical device risk management files throughout product development and post-market activities.
• Apply relevant risk management principles and methodologies, including ISO 14971.
• Identify and document potential hazards, hazardous situations, sequences of events, and foreseeable misuse.
• Conduct and review Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and other structured risk assessment methods.
• Evaluate initial risk estimates based on severity, probability of occurrence, and established risk acceptability criteria.
• Review risk control measures and assess their implementation and effectiveness.
• Maintain traceability between hazards, risk controls, design inputs, verification evidence, and residual risk assessments.
• Assess benefit-risk documentation and review the justification of residual risks.
• Coordinate risk management reviews with design engineering, software, manufacturing, clinical, and quality teams.
• Review design verification and validation evidence supporting risk control implementation.
• Assess risks associated with medical device software, electrical safety, mechanical performance, materials, usability, and cybersecurity where applicable.
• Review usability engineering documentation and foreseeable use-related hazards.
• Support evaluation of manufacturing process risks, supplier-related risks, and component variability.
• Review post-market surveillance information, complaints, adverse event trends, and field safety data for emerging risks.
• Coordinate updates to risk files following design changes, product modifications, complaints, and new safety information.
• Support root-cause analysis and corrective and preventive action investigations involving product safety concerns.
• Prepare risk management reports, review summaries, and technical documentation for internal audits and regulatory assessments.
• Monitor updates to relevant medical device standards, regulatory expectations, and risk management guidance.
• Maintain controlled documentation, revision histories, approval records, and risk traceability matrices.

Qualifications and Experience

• Bachelor's or master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Medical Device Engineering, Quality Management, or a related discipline.
• Significant experience in medical device risk management, quality assurance, design controls, or regulatory documentation.
• Strong knowledge of ISO 14971 and medical device risk management principles.
• Experience developing and maintaining risk management plans, hazard analyses, FMEA records, and risk management reports.
• Understanding of medical device design and development processes, including design verification and validation.
• Familiarity with ISO 13485 quality management systems and applicable medical device regulatory frameworks.
• Experience evaluating risk controls, residual risks, benefit-risk assessments, and risk acceptability criteria.
• Knowledge of medical device software, electrical and mechanical safety, usability engineering, and cybersecurity risks.
• Ability to interpret technical specifications, verification reports, validation evidence, and post-market surveillance data.
• Experience coordinating cross-functional risk reviews and maintaining traceability across technical documentation.
• Familiarity with complaint handling, adverse event analysis, change control, and corrective and preventive action systems.
• Proficiency in risk management tools, spreadsheets, document control platforms, and quality management systems.
• Strong analytical, technical writing, and organizational skills.
• Excellent communication and stakeholder coordination abilities.
• Ability to manage complex technical documentation independently in a fully remote environment.

What We Offer

• Fully remote working arrangement within the UAE employment context.
• Opportunity to contribute to medical device safety, quality, and regulatory readiness.
• Collaboration with multidisciplinary engineering, clinical, quality, and regulatory teams.
• Professional development in medical device risk management and international quality standards.
• A structured environment emphasizing patient safety, technical accuracy, and continuous improvement.

How to Apply

Interested candidates should submit an updated CV highlighting relevant experience in ISO 14971, medical device risk files, FMEA, design controls, and quality management systems.

Application Subject: Application – Senior Medical Device Risk File Specialist (UAE Remote)

Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.

• Role Scope and Authorization: This is a remote risk analysis, technical documentation, and quality oversight position. Physical device testing, laboratory evaluations, equipment operation, manufacturing inspections, clinical assessments, and on-site investigations must be performed by qualified local personnel. Clinical judgments, final product safety determinations, regulatory submissions, conformity assessments, product release decisions, and statutory quality sign-offs must be completed by appropriately authorized professionals. The specialist may prepare risk assessments and recommendations but must not independently approve regulated product safety decisions or replace required qualified-person or regulatory responsibilities.