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Samd Regulatory Jobs (NOW HIRING)

Agilent

$124K - $232K/yr

Interpret and apply regulatory guidance for Software as a Medical Device (SaMD), AI/ML diagnostics, cybersecurity, and algorithm lifecycle management * Partner with R&D, clinical, quality, and ...

Codvo.ai

... SaMD classification, regulatory frameworks (e.g., FDA, MDR), and quality processes. - Lead verification and validation planning and execution for Edge AI products. - Gather and prioritize customer ...

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 ...

Merative

Sr Manager, Regulatory Affairs

In-depth understanding of global medical device and SaMD regulatory frameworks, including FDA QSR/QMSR, ISO13485, Medical Device Single Audit Program (MDSAP), Canadian Medical Devices Regulations, EU ...

New

BSI Prof Serv EHS West

We are seeking engineers with SaMD (Software as a Medical device) in technical capacity which can ... Through our unique combination of consulting, training, assurance and regulatory services we bring ...

New

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Samd Regulatory information

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$40.5K

$95.4K

$138.5K

How much do samd regulatory jobs pay per year?

As of Jul 10, 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.
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Samd Regulatory jobs near you

Technical Project Manager SaMD Remote

Saransh Inc

Raleigh, NC • On-site

Contractor

Re-posted 11 days ago

Job description

Job Description

  • Bachelor’s degree in Computer Science, Engineering, or related field.
  • 8+ years of experience, including 4+ years in technical project management (preferably in SaMD).
  • Proven success in leading cross-functional and multi-site teams.
  • Strong understanding of software development life cycles and medical device regulations.
  • Experience in full-cycle product development—from concept to production launch.

Primary Skills

  • Technical project planning, execution, and integration with broader program goals.
  • Risk and issue management with proactive problem-solving.
  • Strong stakeholder management and communication across teams.
  • High attention to detail and commitment to quality deliverables.
  • Ability to work in fast-paced environments and adapt to changing priorities.
  • Sustaining engineering and project management experience.
  • Metric-driven mindset with a focus on incremental delivery.
  • Experience with Agile methodologies and software development tools.
  • Strong leadership, analytical, and organizational skills.

Secondary Skills / preferred 

  • PMP or equivalent project management certification (preferred).
  • Knowledge of medical device regulations and industry standards.
  • Enthusiastic, dedicated, and collaborative team player.
  • Experience in cybersecurity and regulatory compliance for medical software.
  • Familiarity with documentation best practices and knowledge sharing.