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Samd Regulatory Jobs (NOW HIRING)

Whoop

Senior Program Manager, SaMD

Boston, MA

$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 ...

EnsoData

Backend Software Engineer

Madison, WI · On-site +1

Regulatory & compliance (SaMD) - regulatory adherence, QMS integration and cross function collaboration. About EnsoData EnsoData strives to make healthcare more accurate, efficient, and affordable ...

Whoop

Senior Program Manager, SaMD

Boston, MA

$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 ...

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 ...

Heartflow

Staff Human Factors Engineer

San Francisco, CA

$190K - $250K/yr

... Regulatory, and Quality to make that possible, we want to hear from you. * Establish and drive SaMD human factors and usability strategies in accordance with IEC 62366-1, FDA Human Factors guidance ...

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 ...

Hippocratic AI

Head of Regulatory Affairs

Palo Alto, 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 ...

Synkriom

Be Seen First

Systems Design Engineer-SaMD- Remote

OR · On-site

$48 - $54/hr

... regulatory alignment as the product moves through its lifecycle. This role is open to remote ... SaMD development and regulatory documentation • Working knowledge of ISO 14971; familiarity with ...

Heartflow

Staff Human Factors Engineer

San Francisco, CA · On-site

$190K - $250K/yr

Experience: 8+ years of human factors engineering experience in medical devices, combination products, or regulated healthcare software (SaMD). * Regulatory Fluency: Deep working knowledge of IEC ...

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All JobsSamd Regulatory Jobs

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
Senior Program Manager, SaMD

Senior Program Manager, SaMD

Whoop

Boston, MA

$155K - $185K/yr

Other

Posted 11 days ago

Job description

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.

We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of our Software as a Medical Device programs. This role will partner closely with an existing Program Manager and cross-functional leaders to drive the successful delivery of regulated features.

This is an execution-focused role for someone who has experience working on end-to-end SaMD programs and can operate effectively within an established but evolving system.

RESPONSIBILITIES:
  • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch
  • Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against program milestones
  • Work alongside an existing Program Manager to coordinate multiple SaMD initiatives, ensuring alignment across timelines and dependencies
  • Build and maintain detailed program plans, tracking progress against key deliverables and identifying risks early
  • Support development in compliance with design controls and regulatory requirements, ensuring documentation and processes are followed
  • Coordinate cross-functional activities including: Verification & validation, Clinical studies, Regulatory submission preparation, Design history file (DHF) documentation
  • Identify and proactively manage program risks and blockers, escalating as needed
  • Facilitate clear and consistent communication across stakeholders, including regular program updates
  • Help strengthen and scale program management processes as WHOOP expands its SaMD portfolio
QUALIFICATIONS:
  • 6 - 10+ years of program or project management experience
  • Hands-on experience working on at least one end-to-end SaMD program (from development through regulatory submission/clearance)
  • Familiarity with: FDA regulatory pathways (e.g., 510(k), De Novo), Design controls (21 CFR 820, ISO 13485) and SaMD development lifecycle
  • Experience working within or closely with Quality Management Systems (QMS)
  • Understanding of key standards such as: IEC 62304 & ISO 14971
  • Proven ability to coordinate across Product, Engineering, Clinical, and Regulatory teams
  • Strong organizational, communication, and stakeholder management skills
  • Experience in wearables, digital health, or consumer health products
  • Experience supporting clinical evidence generation or studies
  • Experience working across multiple concurrent programs
  • Background in a technical or scientific field

This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.

Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.

WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility

The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.

At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.

The U.S. base salary range for this full-time position is $155,000 - $185,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. 

In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.

These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements.

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About Whoop

Sourced by ZipRecruiter

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers users (Olympians, Professional Athletes, Fitness Enthusiasts, etc) to perform at a higher level through a deeper understanding of their bodies and daily lives.

Industry

Fitness and sports centers

Company size

501 - 1,000 Employees

Headquarters location

Boston, MA, US

Year founded

2012

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