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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

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 ...

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 · 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 ...

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 ...

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 ...

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 ...

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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 Jul 31, 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:
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Samd Regulatory jobs near you
Infographic showing various Samd Regulatory job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 86% Full Time, 10% Part Time, and 3% Contract. Highlights an 91% Physical, 4% Hybrid, and 5% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Program Manager Samd

Apex Informatics

Mountain View, CA • On-site

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Proven experience in project management, particularly in the medical device or healthcare industry.
- Strong knowledge of Software as a Medical Device (SAMD) regulations and standards.
- Excellent organizational and time management skills.
- Strong communication and interpersonal skills, with the ability to work effectively with diverse teams.
- Proficiency in project management tools and software.
- PMP certification or equivalent is preferred

Apply