Senior Regulatory Affairs Specialist (Fully Remote)

Eko Health, Inc.; United States; Remote; USD 140,000 - 210,000; Full time

Benefits offered by this job

Generous paid time off

Stock incentive plans

Comprehensive benefits

Job summary

Eko Health develops AI-powered digital stethoscopes and ECG tools to help clinicians detect heart and lung disease. The company is venture-backed, recognized by TIME as a top healthtech company, and has a mission-driven team of engineers, physicians, and creatives.

Eko Health seeks a Senior Regulatory Affairs leader to drive QMS remediation and global submissions across medical devices and digital health, partnering with hardware and software teams to release compliant products.

Qualifications

• Bachelor's or higher in Engineering, Life Sciences, or related field.
• 5-8+ years regulatory affairs experience in medical devices or digital health.
• Strong knowledge of FDA 21 CFR 820, EU MDR 2017/745, ISO 13485.

Responsibilities

• Lead QMS and regulatory remediation to align global procedures with FDA QMSR and ISO 13485.
• Manage global regulatory submissions and interactions with Notified Bodies for EU MDR and other markets.
• Serve as RA representative on core project teams for hardware and AI/software releases.

Skills

Regulatory affairs

QMS/ISO 13485

FDA/Regulatory knowledge

EU MDR experience

Cross-functional collaboration

Education

Engineering or Life Sciences degree

Job description

• Lead QMS and regulatory remediation to align global procedures with FDA QMSR and ISO 13485.
• Manage global regulatory submissions and interactions with Notified Bodies for EU MDR and other markets.
• Serve as RA representative on core project teams for hardware and AI/software releases.

Qualifications:

• Bachelor's or advanced degree in Engineering, Life Sciences, or related field.
• 5-8+ years of progressive regulatory affairs experience in medical devices or digital health.
• Strong knowledge of FDA 21 CFR 820, EU MDR 2017/745, ISO 13485, and global submissions.

Why Join Eko Health:

• Opportunity to work on products that impact the health of millions.
• Generous paid-time off, stock incentive plans, and comprehensive benefits.
• Mission-driven team with strong venture backing and industry recognition.

Eko Health

Eko Health develops AI-powered digital stethoscopes and ECG tools to help clinicians detect heart and lung disease. The company is venture-backed, recognized by TIME as a top healthtech company, and has a mission-driven team of engineers, physicians, and creatives.