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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

$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 ...

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.

Elucid

Director of Quality Systems

Boston, MA · On-site

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.

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.

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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Samd Regulatory information

See salary details

$40.5K

$95.4K

$138.5K

How much do samd regulatory jobs pay per year?

As of Sep 14, 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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What job categories do people searching Samd Regulatory jobs look for?

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Samd Regulatory jobs near you
Infographic showing various Samd Regulatory job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 87% Full Time, 9% Part Time, and 2% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Program Manager Samd

Mountain View, CA • On-site

Apex Informatics
IT Services • 1 - 10 employees
Learn more about Apex Informaticsexternal

Full-time

Re-posted 16 days ago

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

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