Senior SaMD Product Safety Risk Manager (ISO 14971)

2105 Merge Canada Holdco Unlimited Liability Company; United States; Hybrid; USD 121,000 - 182,000; Full time

Benefits offered by this job

Remote-first / work from home culture

Flexible vacation

Paid leave

Health, dental, and vision insurance

401k retirement savings plan

Tuition reimbursement

Life insurance

Job summary

Merative seeks a Senior Specialist, Product Safety Risk Management in the United States to oversee ISO 14971-based risk management for medical imaging software devices across the lifecycle. The role partners with engineering, clinical, cybersecurity, human factors, and regulatory affairs to identify, evaluate, control, and monitor safety-related risks, driving CAPAs and continuous improvement.

The position supports post-market surveillance, regulatory submissions, with a hybrid/remote-ready work

Qualifications

• Minimum 5 years in safety risk management in regulated healthcare tech.
• Experience applying ISO14971 to software-based medical devices.
• Strong design controls integration and cross-functional collaboration.
• Excellent communication and problem-solving skills.

Responsibilities

• Owns and maintains risk management process across product lifecycle.
• Collaborates with cross-functional teams to integrate safety risk management into design controls.
• Develops risk management files and documentation.
• Supports post-market safety activities and CAPA.

Skills

Safety risk management

ISO 14971

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Education

Bachelor’s degree in engineering, CS, life sciences

Advanced training in medical device safety risk management

Tools

Jira

Xray Test Management

Microsoft 365

Job description

Merative seeks a Senior Specialist, Product Safety Risk Management in the United States to oversee ISO 14971-based risk management for medical imaging software devices across the lifecycle. The role partners with engineering, clinical, cybersecurity, human factors, and regulatory affairs to identify, evaluate, control, and monitor safety-related risks, driving CAPAs and continuous improvement.

The position supports post-market surveillance, regulatory submissions, with a hybrid/remote-ready work