Regulatory Strategy Lead, Medical Devices Compliance

Semler Scientific Inc; Dallas (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Semler Scientific Inc in Dallas, Texas is seeking a Senior Regulatory Affairs Specialist who will play a key role in regulatory strategy and compliance throughout product lifecycles. Responsibilities include participating in compliance audits, supporting product development in navigating FDA regulations, and assisting with preparing regulatory filings. The ideal candidate must have over 10 years of experience in regulatory affairs, a BS in a health profession or science, and strong analytical and communication skills.

Qualifications

• 10+ years of Regulatory/Clinical experience required.
• Direct experience in FDA regulated Class II software medical device organizations.
• Impeccable attention to detail required.

Responsibilities

• Participate in compliance audits and represent the company in inspections.
• Support the product development team with FDA regulations.
• Assist with preparation of regulatory filings such as 510(k) submissions.

Skills

Regulatory/Clinical experience

Attention to detail

Analytical skills

Technical writing

Education

BS in health profession or science

Tools

ISO 13485:2016 Lead Auditor Certification

Job description

Semler Scientific Inc in Dallas, Texas is seeking a Senior Regulatory Affairs Specialist who will play a key role in regulatory strategy and compliance throughout product lifecycles. Responsibilities include participating in compliance audits, supporting product development in navigating FDA regulations, and assisting with preparing regulatory filings. The ideal candidate must have over 10 years of experience in regulatory affairs, a BS in a health profession or science, and strong analytical and communication skills.