Risk Manager

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

Medical Devices | Fully Remote | 12-Month Contract | 40 Hours per Week

URGENT REQUIREMENT

A leading, globally recognised medical device company is looking for an experienced Risk Management Subject Matter Expert (SME) to support critical risk management remediation activities across its business.

We are specifically looking for an established expert in medical device risk management, with in-depth knowledge of ISO 14971 and a proven track record of applying, reviewing and remediating risk management processes and records.

This is not a general Quality or Regulatory role. You must be a recognised technical SME in risk management, capable of providing authoritative guidance, challenging existing approaches and making sound decisions on the application and conformance of risk management principles.

This is a fully remote, 12-month contract working 40 hours per week.

The Role

You will act as the subject matter expert for risk management and ISO 14971, providing technical leadership and supporting the review, remediation and improvement of risk management procedures, records and activities.

Key responsibilities will include:

• 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.

Experience & Requirements

We are looking for a highly experienced Risk Management SME with extensive practical knowledge of medical device risk management.

You must have:

• A Bachelor's degree in Science, Engineering, Quality or a 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 files and associated documentation.
• Expert knowledge of risk analysis, risk evaluation, risk controls, residual risk and benefit-risk assessments.
• An understanding of how complaints, CAPAs, nonconformances and post-market trends feed into product risk management.
• Previous experience remediating risk management documentation following regulatory findings, audits or inspection observations.
• The confidence and technical authority to challenge existing approaches, advise stakeholders and ensure consistent application of risk management requirements.
• Industry: Medical Devices
• Location: Fully Remote
• Contract: 12 months
• Hours: 40 hours per week
• Start: Urgent

If you are a genuine medical device risk management expert with strong ISO 14971 experience and a proven track record of risk management remediation, we would be keen to hear from you.