Remote Risk Management SME - ISO 14971 Expert (12 Mo)

Maclivaro Limited; Massachusetts; Remote; USD 140,000 - 210,000; Full time

Job summary

Maclivaro Limited is seeking an experienced Risk Management SME for a fully remote, 12-month contract (40 hours per week). You will lead risk management activities, apply ISO 14971, and drive remediation of risk management procedures and records across design and post-market processes.

This senior expert will challenge approaches, provide authoritative guidance, and support audits and inspections. The role requires a Bachelor’s degree in a technical field and 5–10+ years in medical devices or a

Qualifications

• Bachelor's degree in Science, Engineering, Quality or related technical discipline.
• 5-10+ years' experience within medical devices, IVD or a similarly regulated industry, specifically working in risk management.
• Subject matter expert-level knowledge of medical device risk management and ISO 14971.
• Strong practical understanding of ISO/TR 24971 and its application.
• Demonstrable experience managing risk management activities across both product design and post-market processes.
• Hands-on experience reviewing, updating and remediating risk management documentation.
• Ability to challenge existing approaches and provide authoritative guidance.

Responsibilities

• Review and revise existing risk management procedures, forms and risk management file records.
• Support the preparation, review and updating of current risk management documentation.
• Perform risk analysis, risk evaluation and assessment of risk control measures, including product and process residual risk.
• Prepare and support documentation for formal risk management reviews.
• Provide expert guidance on the application of ISO 14971 and ISO/TR 24971 across the organisation.
• Evaluate and remediate the application of risk management principles within design controls and post-market processes.
• Ensure consistent application of risk acceptability criteria, benefit-risk determinations and residual risk evaluations.
• Assess post-market signals, including complaints, nonconformances, CAPAs and trends, to determine their impact on product risk.
• Ensure post-market information is appropriately reflected in risk management files and benefit-risk assessments.
• Support remediation activities to ensure documentation and outputs are robust, defensible and inspection-ready.
• Provide support during audits, regulatory inspections and follow-up activities relating to risk management findings.
• Establish sustainable controls and demonstrate effective remediation of identified gaps.

Skills

Risk management

ISO 14971

Documentation remediation

Regulatory audits

Education

Bachelor's degree in Science/Engineering/Quality

Job description

Maclivaro Limited is seeking an experienced Risk Management SME for a fully remote, 12-month contract (40 hours per week). You will lead risk management activities, apply ISO 14971, and drive remediation of risk management procedures and records across design and post-market processes.

This senior expert will challenge approaches, provide authoritative guidance, and support audits and inspections. The role requires a Bachelor’s degree in a technical field and 5–10+ years in medical devices or a