Senior Regulatory Affairs Lead - Remote SaMD

53 Stations; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive base salary

Stock options

Health benefits

Flexible work environment

Job summary

Function Health in the United States is seeking a Senior Regulatory Affairs Specialist to partner with product and research teams, shaping regulatory paths early, assessing claims, and guiding FDA submissions for SaMD and medical devices.

You will maintain audit-ready regulatory records, support international submissions (EU/UK), and help build scalable regulatory processes across lab testing and AI-enabled software.

Qualifications

• 5+ years of regulatory affairs experience with medical devices, software as a medical device (SaMD), or diagnostics.
• Bachelor's degree in engineering, life sciences, or a related technical field.
• Hands-on experience with 510(k), De Novo, or Pre-Submission work, including preparing submission content.
• Working knowledge of FDA device regulations and guidance, ISO 13485, ISO 14971, and IEC 62304.

Responsibilities

• Set regulatory path for new features from requirements stage.
• Review labeling, claims, and AI outputs against device and wellness boundaries.
• Prepare regulatory launch reviews and submission packages for sign-off.
• Coordinate 510(k), De Novo, and Pre-Submission efforts.

Skills

Regulatory affairs

Medical devices

SaMD

Regulatory submissions

Regulatory writing

FDA regulations

ISO 13485

EU MDR

QMS/820

Education

Bachelor's degree

Job description

Function Health in the United States is seeking a Senior Regulatory Affairs Specialist to partner with product and research teams, shaping regulatory paths early, assessing claims, and guiding FDA submissions for SaMD and medical devices.

You will maintain audit-ready regulatory records, support international submissions (EU/UK), and help build scalable regulatory processes across lab testing and AI-enabled software.