Senior Clinical Safety Manager - FDA-Regulated Devices & LDT

Medix™; Phoenix (AZ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Job summary

Medix seeks a Clinical Safety Manager to establish and continuously improve clinical safety processes for LDT and medical device studies in a regulated healthcare environment. You will lead safety planning, adverse event management, risk assessments, and safety reporting, ensuring regulatory compliance.

You will partner with cross-functional teams to align clinical safety activities with quality systems, post-market processes, and leadership direction, contributing to program growth and audit

Qualifications

• 5+ years in clinical research safety or regulated healthcare settings.
• Experience supporting sponsor-led device/IVD/LDT studies and safety reporting.
• Knowledge of FDA clinical research and medical device requirements (21 CFR parts 803/812/820).
• Experience documenting adverse events and safety issues.
• Ability to collaborate with cross-functional teams and regulatory bodies.

Responsibilities

• Establish, implement, and continuously improve clinical research safety processes for LDT/medical device studies.
• Oversee safety planning, adverse event management, risk assessments, and safety reporting.
• Maintain regulatory documentation and ensure inspection readiness.
• Collaborate with cross-functional teams to align safety with quality systems and post-market processes.

Skills

Clinical safety experience

Adverse event assessment

Regulatory compliance

IRB/EC interactions

Education

Bachelor's degree in life sciences or related field

Tools

FDA regulations knowledge (21 CFR Parts 803/812/820)

Job description

Medix seeks a Clinical Safety Manager to establish and continuously improve clinical safety processes for LDT and medical device studies in a regulated healthcare environment. You will lead safety planning, adverse event management, risk assessments, and safety reporting, ensuring regulatory compliance.

You will partner with cross-functional teams to align clinical safety activities with quality systems, post-market processes, and leadership direction, contributing to program growth and audit