Regulatory Affairs Specialist
New
A
ArchyHealth Tech
United StatesFull-TimeSenior
Salary100,000 - 150,000 USD per year
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Job Details
- Experience
- 5+ years
- Required Skills
- HIPAA
Requirements
- 5+ years in regulatory affairs at a medical device, digital health, or healthcare SaaS company.
- Hands-on experience across the full 510(k) lifecycle for SaMD or AI/ML-enabled software.
- Strong working command of 21 CFR Part 820 / QMSR, IEC 62304, ISO 14971, and ISO 13485.
- Experience with FDA SaMD and AI/ML guidance and premarket cybersecurity expectations.
- Ability to read software specs and write requirements for engineers.
- Proven experience operationalizing compliance via SOPs, training, and audits.
- Strong written communication for FDA submissions and technical policies.
Responsibilities
- Own the lifecycle of Archy Imaging's 510(k) clearance including change assessments and submissions.
- Maintain the Quality Management System.
- Execute post-market programs including MDR reporting and surveillance.
- Evolve software development lifecycle to meet IEC 62304 and ISO 14971 standards.
- Lead regulatory strategy for new product classifications and pathways.
- Partner with engineering/product to embed regulatory requirements into the development process.
- Manage HIPAA compliance and internal policies.
- Lead SOC 2 Type II program including auditor management and evidence collection.
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