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Samd Regulatory Jobs (NOW HIRING)

WHOOP

Senior Program Manager, SaMD

Boston, MA · On-site

$126K - $126K/yr

Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...

WHOOP

Senior Program Manager, SaMD

Boston, MA · On-site

$126K - $126K/yr

Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...

WHOOP

Senior Program Manager, SaMD

Boston, MA · On-site

$126K - $126K/yr

Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...

WHOOP

Senior Program Manager, SaMD

Boston, MA · On-site

$126K - $126K/yr

Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...

Bausch + Lomb

Director, Product Owner

OR · On-site +1

Partner with the CTO on architecture, data governance, AI model decisions, and FDA cybersecurity guidance in support of a future SaMD regulatory pathway * Drive fast iteration cycles, using design ...

Whoop

Senior Program Manager, SaMD

Boston, MA

$155K - $185K/yr

We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the ... Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and ...

Whoop

Director, Clinical Science

Boston, MA · On-site

$86K - $118K/yr

This role requires deep expertise in SaMD clinical development, including study design, endpoint development, clinical validation, regulatory strategy, and evidence generation. As both a strategic ...

Whoop

Director, Clinical Science

Boston, MA · On-site +1

$86K - $118K/yr

This role requires deep expertise in SaMD clinical development, including study design, endpoint development, clinical validation, regulatory strategy, and evidence generation. As both a strategic ...

Whoop

Senior Program Manager, SaMD

Boston, MA · On-site

$155K - $185K/yr

We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the ... Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and ...

Whoop

Senior Program Manager, SaMD

Boston, MA

$155K - $185K/yr

We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the ... Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and ...

Whoop

Director, Clinical Science

Boston, MA · On-site +1

$86K - $118K/yr

This role requires deep expertise in SaMD clinical development, including study design, endpoint development, clinical validation, regulatory strategy, and evidence generation. As both a strategic ...

Symmetrio

Regulatory Affairs Manager-US

This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment. Key Responsibilities * Lead preparation and ...

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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.
Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)

Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)

Saviance

Boston, MA • Remote

Other

Posted 11 days ago

Job description

Job Title: Digital Health FDA Consultant (SaMD - AI/Generative AI/LLMs)
Location: Remote (USA or India)
Engagement: Contract (Part-Time)
About the Role
We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands-on experience guiding AI-driven products through the FDA clearance process. The ideal consultant will have strong knowledge of Generative AI, Large Language Models (LLMs), and AI-enabled disease diagnosis workflows, and can advise our team on regulatory, compliance, safety, and validation requirements.
This role is ideal for someone who has supported early-stage health tech or digital health companies in successfully navigating SaMD regulatory pathways.
Key Responsibilities
  • Provide end-to-end regulatory guidance for FDA SaMD submissions (510(k), De Novo, Pre-Sub, etc.)
  • Develop and review documentation including:
    • SaMD Risk Analysis (ISO 14971)
    • Clinical Evaluation Reports (CER)
    • Software Documentation per FDA and IMDRF
    • Validation/Verification Plans (V&V)
    • Human Factors and Usability documentation
  • Advise on regulatory strategy for AI/ML-enabled medical software, including:
    • Continuous learning algorithms
    • Model transparency, explainability, and bias mitigation
    • Real-world performance monitoring frameworks
  • Guide compliance with:
    • FDA's AI/ML SaMD Action Plan
    • Good Machine Learning Practices (GMLP)
    • 21 CFR Part 820, Part 11, and FDA Digital Health Policies
  • Support development teams by translating regulatory requirements into:
    • Product requirements
    • Model performance metrics
    • Validation/clinical testing strategies
  • Assess and advise on the use of Generative AI and LLMs for disease diagnosis and clinical decision support
  • Prepare teams for FDA interactions and Q-Sub meetings
  • Conduct gap assessments for regulatory readiness and documentation completeness
Required Qualifications
  • 5-10+ years of experience in digital health, FDA regulatory consulting, or medical software compliance
  • Proven experience in FDA clearance for Software as a Medical Device (SaMD)
  • Hands-on experience with AI/ML-based medical devices, including algorithm validation and clinical evidence requirements
  • Familiarity with Generative AI, LLMs, and their application in diagnostics or decision-support tools
  • Strong understanding of:
    • IMDRF SaMD Framework
    • IEC 62304 (software lifecycle)
    • ISO 14971 (risk management)
    • FDA Guidance on Clinical Decision Support (CDS)
  • Demonstrated capability to work with engineering, data science, and clinical teams
  • Excellent communication skills and ability to simplify regulatory concepts for technical teams
Preferred Qualifications
  • Experience with GenAI-enabled clinical decision support or diagnostic models
  • Prior work with health-tech startups or AI-driven digital health products
  • Understanding of HIPAA, PHI handling, and healthcare data governance
  • Knowledge of EU MDR/IVDR (bonus but not required)
Saviance logo

About Saviance

Sourced by ZipRecruiter

Saviance is a modern consulting firm providing a variety of professional services to its clients in the US. We bring twenty three years of experience to the table. Our consultants are qualified experts and extremely talented. We understand the business behind the technology, and work with many of the top Fortune 100 companies and provide innovative, scalable, robust and secure solutions. At the forefront of the Staffing and IT Solutions industry, Saviance is certified by NMSDC as a Tier 1, Minority Business Enterprise (MBE) . We are a self- certified Small Business and self- certified Woman Owned Business committed to maximizing global workforce solutions on behalf of our clients, empowering businesses and talent through applied human intelligence. We are a Diversity Supplier with global reach specializing in a business services blend of talent, technology, and a relentless commitment to customer success. It’s our diversity that’s acts as a core component of our culture, our approach to business, and the opportunities we provide to our clients and our employees.

Industry

It services

Company size

201 - 500 Employees

Headquarters location

East Rutherford, NJ, US

Year founded

1999

Social media

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