Senior Safety Risk Manager - SaMD & Medical Software

Merative; United States; Hybrid; USD 121,000 - 182,000; Full time

Benefits offered by this job

Remote work culture

Flexible vacation

Paid leave

Health insurance

Dental insurance

Vision insurance

401k

Tuition reimbursement

Life insurance

EAP

Job summary

Merative is seeking a Senior Specialist in Product Safety Risk Management to own ISO14971-aligned risk management across the full product lifecycle, from concept through post-market surveillance. You will partner with engineering, clinical, cybersecurity, humans factors and regulatory affairs to proactively identify, assess, control, and monitor safety risks and drive improvements.

The role emphasizes hazard analyses, FMEAs, risk controls, CAPAs and regulatory submissions.

Qualifications

• 5+ years in safety risk management for healthcare technology or regulated industries.
• ISO14971 applied to software-based medical devices across lifecycle.
• Strong understanding of design controls integration with safety risk management.
• Excellent analytical, problem-solving and risk-based decision-making abilities.
• Proven collaboration across multidisciplinary teams and influencing without authority.
• Strong organizational and project management skills with attention to detail.
• Excellent written and verbal communication for risk documentation.
• Ability to work independently in a collaborative team environment.

Responsibilities

• Owns safety risk management process per ISO14971 across product lifecycle.
• Executes hazard identification, risk analysis, evaluation, control and residual risk.
• Integrates safety risk management into design controls and development processes.
• Guides interpretation of safety regulations and internal QMS procedures.
• Maintains risk management files and analyses (FMEAs, fault trees, benefit-risk).
• Collaborates with clinical, usability, cybersecurity teams for comprehensive risk control.
• Assesses effectiveness of controls and ensures traceability to verification/validation.
• Supports post-market safety activities including HHEs and CAPA.

Skills

Risk management

Hazard analysis

Regulatory knowledge

Analytical thinking

Cross-functional collaboration

Problem solving

Independent work

Education

Bachelor’s degree in engineering or related field

Medical device safety risk management certification

Experience with agile environments

Tools

Jira

Xray Test Management

Microsoft 365

Job description

Merative is seeking a Senior Specialist in Product Safety Risk Management to own ISO14971-aligned risk management across the full product lifecycle, from concept through post-market surveillance. You will partner with engineering, clinical, cybersecurity, humans factors and regulatory affairs to proactively identify, assess, control, and monitor safety risks and drive improvements.

The role emphasizes hazard analyses, FMEAs, risk controls, CAPAs and regulatory submissions.