Common questions about samd jobs careers in the medical device industry. Jobs are aggregated daily from multiple sources and filtered to this category.
- What does a SaMD regulatory specialist do?
- A SaMD regulatory specialist ensures software-based medical devices comply with FDA and international regulations. Key responsibilities include: Software Classification - Determining FDA Class I/II/III and EU MDR classification for software, IEC 62304 Compliance - Ensuring software development lifecycle meets standards, Cybersecurity - Addressing FDA premarket cybersecurity guidance, AI/ML Documentation - Preparing predetermined change control plans for adaptive algorithms, Clinical Validation - Supporting clinical evidence for software performance claims.
- What qualifications are needed for SaMD jobs?
- SaMD positions typically require: Education: Bachelor's or Master's in software engineering, biomedical engineering, computer science, or related field. Experience: 3-5 years for mid-level, 7+ years for senior roles. Technical Knowledge: IEC 62304, IEC 62443 (cybersecurity), FDA software guidance, EU MDR Annex I software requirements. Skills: Software development understanding, risk management (ISO 14971), technical writing. Bonus: Experience with AI/ML algorithms, cloud-based medical devices, or mobile health apps.
- What is the salary range for SaMD regulatory jobs?
- SaMD regulatory salaries are among the highest in the field: Specialist (3-5 years): $100,000-$130,000, Senior Specialist (5-8 years): $130,000-$160,000, Manager (7-10 years): $150,000-$190,000, Director (10+ years): $180,000-$250,000+. Digital health startups often offer equity compensation. Consulting rates for SaMD experts can exceed $200-300/hour due to specialized expertise.
