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Samd Regulatory Jobs (NOW HIRING)

Heartflow

Staff Human Factors Engineer

San Francisco, CA

$190K - $250K/yr

... Regulatory, and Quality to make that possible, we want to hear from you. * Establish and drive SaMD human factors and usability strategies in accordance with IEC 62366-1, FDA Human Factors guidance ...

Irhythmtech

Manager, Regulatory Affairs

San Francisco, CA · On-site +1

$127K - $165K/yr

Lead regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance * Preparing international and domestic regulatory ...

Hippocratic AI

Head of Regulatory Affairs

Menlo Park, CA · On-site

$176K - $233K/yr

Help develop and support regulatory strategies and submissions for AI-enabled SaMD products, including classification, marketing applications (e.g., NDAs, De Novo, 510(k)), and pre-submission ...

Heartflow

Staff Human Factors Engineer

San Francisco, CA · On-site

$190K - $250K/yr

Experience: 8+ years of human factors engineering experience in medical devices, combination products, or regulated healthcare software (SaMD). * Regulatory Fluency: Deep working knowledge of IEC ...

Agilent

$124K - $232K/yr

Interpret and apply regulatory guidance for Software as a Medical Device (SaMD), AI/ML diagnostics, cybersecurity, and algorithm lifecycle management * Partner with R&D, clinical, quality, and ...

Codvo.ai

... SaMD classification, regulatory frameworks (e.g., FDA, MDR), and quality processes. - Lead verification and validation planning and execution for Edge AI products. - Gather and prioritize customer ...

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All JobsSamd Regulatory Jobs

Samd Regulatory information

See salary details

$40.5K

$95.4K

$138.5K

How much do samd regulatory jobs pay per year?

As of Jun 19, 2026, the average yearly pay for samd regulatory in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

What are some common challenges faced by professionals in SaMD Regulatory roles, and how can they best address them?

Professionals in SaMD (Software as a Medical Device) Regulatory roles frequently encounter challenges such as keeping up with rapidly evolving regulations, ensuring software development aligns with regulatory requirements, and managing cross-functional communication between developers, clinical experts, and regulatory authorities. Staying current with international standards and guidance documents is essential, as is fostering close collaboration with engineering and quality teams to ensure compliance throughout the product lifecycle. Proactively participating in industry forums and engaging in ongoing professional development can help address these challenges and support successful regulatory submissions.

What are the key skills and qualifications needed to thrive as a SaMD Regulatory Specialist, and why are they important?

To excel as a SaMD (Software as a Medical Device) Regulatory Specialist, you need in-depth knowledge of medical device regulations, software development life cycles, and a relevant degree in life sciences, engineering, or regulatory affairs. Familiarity with regulatory frameworks like FDA, EU MDR, and ISO 13485, as well as experience with documentation tools and quality management systems, is essential. Strong analytical skills, attention to detail, and effective communication are crucial soft skills for interpreting regulations and collaborating with cross-functional teams. These competencies ensure regulatory compliance, accelerate market approvals, and safeguard patient safety in the rapidly evolving digital health landscape.

What is the difference between Samd Regulatory vs Samd Quality Assurance?

AspectSamd RegulatorySamd Quality Assurance
CertificationsRegulatory Affairs Certification (RAC), FDA, ISOISO 9001, Six Sigma, Quality Auditor
Work EnvironmentRegulatory agencies, compliance departmentsManufacturing, product testing, quality departments
Industry UsagePharmaceuticals, medical devices, biotechManufacturing, consumer goods, healthcare

Samd Regulatory focuses on ensuring products meet legal and regulatory standards, working closely with authorities. Samd Quality Assurance emphasizes maintaining product quality through testing, audits, and process improvements. While both roles aim to ensure product safety and compliance, Samd Regulatory is more about legal adherence, whereas Samd Quality Assurance centers on quality control processes.

What are SAMD regulatory professionals?

SAMD regulatory professionals are experts who ensure that software as a medical device (SAMD) complies with relevant global regulations, such as those set by the FDA, EMA, or other regulatory authorities. Their responsibilities include interpreting laws and guidelines, preparing documentation for regulatory submissions, and liaising with agencies to gain approval for the software’s use in healthcare settings. These professionals play a crucial role in helping companies navigate the complex regulatory landscape to bring safe, effective medical software to market.
More about Samd Regulatory jobs
What cities are hiring for Samd Regulatory jobs? Cities with the most Samd Regulatory job openings:
What states have the most Samd Regulatory jobs? States with the most job openings for Samd Regulatory jobs include:
What job categories do people searching Samd Regulatory jobs look for? The top searched job categories for Samd Regulatory jobs are:
Samd Regulatory jobs near you
Infographic showing various Samd Regulatory job openings in the United States as of June 2026, with employment types broken down into 68% Full Time, 13% Part Time, and 19% Contract. Highlights an 81% In-person, and 19% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.
Staff Human Factors Engineer

Staff Human Factors Engineer

Heartflow

San Francisco, CA

$190K - $250K/yr

Other

Posted 5 days ago

Job description

We are seeking an experienced Staff Human Factors Engineer to lead usability engineering across our AI-driven medical device portfolio. Reporting to the Sr. Director of Systems Engineering, you will drive the human factors strategy and lifecycle from use-related risk analysis through formative evaluation and summative validation.

At HeartFlow, we are working to transform coronary artery disease from the leading cause of death into a condition that can be managed for life. If you are energized by running rigorous usability studies, translating clinical workflow insights into design decisions, and partnering across Product, Engineering, Clinical, Regulatory, and Quality to make that possible, we want to hear from you.

Job Description
  • Establish and drive SaMD human factors and usability strategies in accordance with IEC 62366-1, FDA Human Factors guidance, and EU MDR expectations.
  • Execute and document usability engineering evaluations, including task analyses and human factors studies.
  • Author formative and summative usability study protocols.
  • Plan, coordinate, and moderate formative and summative usability studies.
  • Perform root cause analysis of use errors and aggregate data for presentations and formal reports.
  • Partner with external vendors as required to execute human factors evaluations (recruiting, study design, execution, analysis, & reporting)
  • Author and update usability risk analyses in collaboration with cross-functional stakeholders.
  • Partner with Quality teams to address potential complaints related to usability on-market products.
  • Work with design teams to create clinician-centric and compliant designs.
  • Assist in developing usability engineering processes for Quality system improvements.
  • Represent HeartFlow as the subject matter expert in HFE-related regulatory inquiries, agency discussions, and audits.
Required Qualifications
  • Education: BS/MS in Human Factors Engineering, Human-Computer Interaction, Biomedical Engineering, Cognitive/Experimental Psychology, or related discipline.
  • Experience: 8+ years of human factors engineering experience in medical devices, combination products, or regulated healthcare software (SaMD).
  • Regulatory Fluency: Deep working knowledge of IEC 62366-1, FDA Human Factors guidance (2016), ISO 14971, and EU MDR usability expectations.
  • Validation Track Record: Demonstrated ownership of summative human factors studies supporting successful regulatory submissions (e.g., 510(k), De Novo, PMA, or MDR technical documentation).
  • Methods: Proficiency in task analysis, use-FMEA/URRA, contextual inquiry, and moderated usability testing (in-person and remote).
  • Communication: Strong written and verbal communication skills; track record of authoring HFE reports that withstand regulatory review.
  • Travel: Available for up to 25% of travel, including both domestic and international trips (must be cleared for international travel).
How You Stand Out
  • Clinical Domain: Experience with cardiovascular imaging, CT/MRI workflows, interventional cardiology, or AI/ML-enabled clinical decision support.
  • Simulation Experience: Experience running simulated-use studies in high-fidelity clinical or cath-lab simulation environments.
  • Adjacent Standards: Familiarity with IEC 60601-1-6, IEC 62304, ISO 13485, and 21 CFR 820 design controls.
  • Certification: CHFP or CPE certification.

A reasonable estimate of the base salary compensation range is $190,000 to $250,000, bonus, and equity. #LI-IB1

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