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Samd Regulatory Jobs (NOW HIRING)

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 ...

Elucid

Director of Quality Systems

Boston, MA · On-site

$175K - $225K/yr

You'll shape how a novel, machine learning powered SaMD product is developed, cleared globally and evolves over its lifecycle, partnering closely with R&D, Regulatory Affairs, Clinical and Product.

Senseye

Design Quality Engineer, SaMD

Austin, TX · On-site

$100K - $125K/yr

We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...

Elucid

Director of Quality Systems

Boston, MA · On-site

$175 - $225/hr

You'll shape how a novel, machine learning powered SaMD product is developed, cleared globally and evolves over its lifecycle, partnering closely with R&D, Regulatory Affairs, Clinical and Product.

Senseye

Design Quality Engineer, SaMD

Austin, TX · On-site

$100K - $125K/yr

We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...

Senseye

Design Quality Engineer, SaMD

Austin, TX · On-site

$100K - $125K/yr

We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...

Oura

Senior Regulatory Affairs Specialist

Support regulatory operations lead for SaMD products across development, submission, launch, and post-market phases * Coordinate preparation, compilation, publishing, and archival of regulatory ...

Ōura

Senior Regulatory Affairs Specialist

Support regulatory operations lead for SaMD products across development, submission, launch, and post-market phases * Coordinate preparation, compilation, publishing, and archival of regulatory ...

Irhythmtech

Manager, Regulatory Affairs

$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 ...

iRhythm Holdings, Inc.

Manager, Regulatory Affairs

$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 ...

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 ...

Innolitics LLC

$160 - $200/hr

About the Role We're hiring a Principal Regulatory Affairs Specialist to help our clients building AI/ML-enabled Software as a Medical Device (SaMD) through the FDA. This is primarily a strategic ...

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 ...

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Samd Regulatory information

See salary details

$40.5K

$95.4K

$138.5K

How much do samd regulatory jobs pay per year?

As of Aug 21, 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 is a SaMD Regulatory professional?

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.

What are the key skills and qualifications needed to thrive as a SaMD Regulatory specialist?

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 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 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.

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?

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Samd Regulatory jobs near you
Infographic showing various Samd Regulatory job openings in the United States as of August 2026, with employment types broken down into 2% As Needed, 86% Full Time, 9% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Regulatory Affairs Manager-US

Symmetrio

Remote

Full-time

Re-posted 12 days ago

Job description

Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. 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 submission of FDA 510(k) filings for healthcare software and digital health products
  • Develop and execute regulatory strategies supporting product development and commercialization
  • Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance
  • Interpret FDA guidance related to medical device software and digital health technologies
  • Partner with global regulatory teams to support international regulatory initiatives

Requirements
  • 5-10+ years of regulatory affairs experience in medical devices or healthcare software
  • Proven experience with FDA 510(k) submissions, ideally for software-based medical devices
  • Strong knowledge of SaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304)
  • Experience working within a multinational organization
  • Strong cross-functional collaboration and communication skills

Apply