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Samd Regulatory Jobs (NOW HIRING)

Codvo.ai

$203K/yr

Ensure compliance with SaMD classification, regulatory standards, and quality processes. Document design specifications, test protocols, and validation reports in accordance with regulatory ...

Radiology Partners

Regulatory Affairs Manager

$125K - $150K/yr

Bachelor's degree in Engineering, Science, or related field (advanced degree preferred) * 3-5+ years of regulatory affairs experience in medical devices, SaMD, or similar environment * Experience ...

radiology partners

Regulatory Affairs Manager

$125K - $150K/yr

Bachelor's degree in Engineering, Science, or related field (advanced degree preferred) * 3-5+ years of regulatory affairs experience in medical devices, SaMD, or similar environment * Experience ...

Radiology Partners

Regulatory Affairs Manager

$125K - $150K/yr

Bachelor's degree in Engineering, Science, or related field (advanced degree preferred) * 3-5+ years of regulatory affairs experience in medical devices, SaMD, or similar environment * Experience ...

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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.
(US) Edge AI Architect- CUDA / C++ / Computer Vision

(US) Edge AI Architect- CUDA / C++ / Computer Vision

Codvo.ai

On-site

$203K/yr

Full-time

Posted 22 days ago

Job description

Job Description: Edge AI Architect - CUDA / C++ / Computer Vision
Experience Level: 10+ Years
Department: Edge AI & Embedded Systems

About the Role:

We are looking for a highly motivated and technically proficient Edge AI Engineer with a strong background in Edge AI devices, computer vision algorithms, and AI model deployment in the MedTech domain. This role is pivotal in developing and optimizing AI-powered medical devices that operate at the edge, ensuring performance, reliability, and compliance with healthcare standards.


Key Responsibilities:

           Design, develop, and optimize AI models for deployment on Edge AI devices in medical applications.

           Implement and evaluate computer vision algorithms for real-time video and image analysis.

           Collaborate with cross-functional teams to integrate AI solutions into embedded systems and medical devices.

           Ensure compliance with SaMD classification, regulatory standards, and quality processes.

           Document design specifications, test protocols, and validation reports in accordance with regulatory requirements.

           Communicate technical findings and project updates effectively to stakeholders.


Required Qualifications:

           Bachelor's or Master's degree in Computer Engineering, Electrical Engineering, Biomedical Engineering, or related field.

           8+ years of experience in AI engineering, preferably in medical devices or healthcare technology.

           Strong experience with Edge AI hardware platforms (e.g., NVIDIA Jetson, Google Coral, Intel Movidius).

           Strong experience in CUDA, C++ writing drivers with contract manufactured Edge AI devices with custom GPU configuration

           Proficiency in computer vision frameworks (e.g., OpenCV, TensorFlow, PyTorch) and model optimization tools.

           AI/ML Acumen (Crucial) Required: Strong LLM, RAG, agentic architecture understanding

           Understanding of SaMD regulations, ISO 13485, IEC 62304, and related standards.

           Experience with embedded systems development and real-time processing.

           Excellent verbal and written communication skills.


Nice to Have:

           Experience testing or developing AI systems for surgical applications.

           Familiarity with test data validation for computer vision and video-based AI models.

           Knowledge of risk management processes (ISO 14971) and cybersecurity standards in healthcare.

           Experience with cloud-edge integration and CI/CD pipelines for AI deployment.

Employment Type: FULL_TIME

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