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Samd Regulatory Jobs (NOW HIRING)

BioTalent

Director Clinical Affairs

Boston, MA · On-site

$163K - $215K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

Santa Rosa, CA · On-site

$164K - $216K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

San Mateo, CA · On-site

$170K - $225K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

Sunnyvale, CA · On-site

$178K - $235K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

Hayward, CA · On-site

$172K - $227K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

Fremont, CA · On-site

$164K - $216K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

Alameda, CA · On-site

$174K - $229K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

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 ...

BioTalent

Director Clinical Affairs

Sonoma, CA · On-site

$168K - $221K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

San Francisco, CA · On-site

$176K - $233K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

BioTalent

Director Clinical Affairs

San Jose, CA · On-site

$175K - $232K/yr

Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance * Manage CRO and clinical vendor relationships, including contract negotiation and ...

Overjet

Head of Regulatory

San Mateo, CA · On-site

$170K - $225K/yr

S. FDA (21 CFR Part 820, SaMD guidance) * Canada's Medical Devices Regulations * EU MDR and IVDR (including Notified Body processes) * UK Medical Device Regulations * Australian TGA (including ...

Overjet

Head of Regulatory

San Mateo, CA · On-site

$170K - $225K/yr

S. FDA (21 CFR Part 820, SaMD guidance) * Canada's Medical Devices Regulations * EU MDR and IVDR (including Notified Body processes) * UK Medical Device Regulations * Australian TGA (including ...

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All JobsGovernment JobsGovernment Services JobsRegulatory Affairs Specialist 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 Sep 15, 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?

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 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.

Director Clinical Affairs

Boston, MA • On-site

BioTalent
See more jobs at BioTalentexternal

$163K - $215K/yr

Other

Posted 25 days ago

Key responsibilities

  • Own the full device/SaMD clinical lifecycle from study design through trial execution, final report, and post-market surveillance

  • Lead clinical study activities including feasibility, site selection, enrollment, monitoring, and close-out

  • Manage clinical data operations, including eCRF design, data review, and vendor coordination

Job description

Director of Clinical Affairs

We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on, operationally intense role for someone who has taken devices or SaMD from earliest-stage concept all the way through trial completion and into post-market surveillance — not just a single phase of the lifecycle.

What You'll Do

  • Own the full device/SaMD clinical lifecycle — from early-stage study design through trial execution, final study report, and post-market surveillance
  • Develop study design from scratch in close collaboration with internal management, regulatory advisors, reimbursement specialists, and KOL advisory committees
  • Lead clinical study execution — feasibility, site selection, activation, enrollment, monitoring, and close-out
  • Write and manage IRB/Ethics submissions, informed consent forms, and study essential documents
  • Select, qualify, and oversee third-party clinical sites and investigators as primary point of contact
  • Manage clinical data operations — eCRF design, data review, query resolution, vendor coordination
  • Develop study timelines, budgets, and risk mitigation plans, reporting clearly to leadership
  • Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, and SaMD guidance
  • Manage CRO and clinical vendor relationships, including contract negotiation and performance oversight
  • Collaborate cross-functionally with regulatory, product, engineering, and legal teams
  • Support RA/QA peers on FDA interactions, pre-subs, and 510(k) submissions
  • Build and scale the clinical operations function — SOPs, templates, and tracking systems
  • Maintain post-market surveillance activities, including adverse event monitoring and reporting


What You Bring

  • Minimum B.S. Degree with 10+ years hands-on clinical operations experience (5+ in leadership) running trials for FDA-regulated medical devices, SaMD/digital health, or combination products
  • Demonstrated experience owning a device or SaMD through the complete lifecycle — from initial concept and study design through trial completion and post-market surveillance
  • Track record of building study designs from scratch alongside key internal and external stakeholders
  • Experience with biosensing devices, consumer health tech, or wellness platforms pursuing clinical validation
  • Familiarity with RWE study designs and decentralized/hybrid trial models
  • Startup or scale-up experience building processes from scratch
  • Experience supporting breakthrough device designations or pre-sub meetings
  • Experience launching studies across multiple regions/countries, with direct exposure to varying regulatory bodies and government requirements
  • Track record of trials leading to FDA clearances/approvals or labeling expansions
  • Experience managing third-party clinical sites end-to-end (selection through close-out)
  • Proven ability authoring IRB/Ethics submissions, ICFs, and clinical protocols
  • 7+ years cross-functional program management across clinical, engineering, and regulatory
  • Strong clinical data management knowledge (eCRF, data cleaning, query management, database lock)
  • Fluency in FDA device regulations (IDE, De Novo, 510(k)), ICH-GCP, ISO 14155, and SaMD guidance
  • Experience with study budgeting, vendor management, and CRO oversight
  • KOL relationship-building experience

Apply