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Samd Regulatory Jobs in Texas (NOW HIRING)

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 ...

Enovis

Senior Regulatory Affairs Specialist

Austin, TX · On-site

This role will be working on hardware and software as a medical device (SaMD) products for distribution as the Senior RA Specialist. This role will develop and champion regulatory strategies, work ...

Enovis

Senior Regulatory Affairs Specialist

Austin, TX · On-site

This role will be working on hardware and software as a medical device (SaMD) products for distribution as the Senior RA Specialist. This role will develop and champion regulatory strategies, work ...

Heartflow

Director - Post Market Quality

Austin, TX

Proven track record of successfully leading or playing a key SME role in regulatory inspections (FDA, Notified Body). Preferred: * Direct experience with AI/ML-driven SaMD and cloud-based medical ...

Heartflow

Director - Post Market Quality

Austin, TX · On-site

Proven track record of successfully leading or playing a key SME role in regulatory inspections (FDA, Notified Body). Preferred: * Direct experience with AI/ML-driven SaMD and cloud-based medical ...

Socket.dev

Director - Post Market Quality

Austin, TX · On-site

$180 - $225/hr

Proven track record of successfully leading or playing a key SME role in regulatory inspections (FDA, Notified Body). Preferred * Direct experience with AI/ML- driven SaMD and cloud- based medical ...

Neuralink

Software Design Quality Engineer

Austin, TX · On-site

... SaMD) / Software in a Medical Device (SiMD). * Prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA, or equivalent) and interfacing with FDA ...

Future Ventures

Software Design Quality Engineer

Austin, TX · On-site

$103 - $191/hr

... SaMD) / Software in a Medical Device (SiMD). * Prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA, or equivalent) and interfacing with FDA ...

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Samd Regulatory information

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.

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Samd Regulatory jobs near you

Regulatory Compliance Lead

Verily Life Sciences

Dallas, TX • On-site

Full-time

Re-posted 8 days ago

Job description

Who We Are
Verily Health is a data platform and technology company purpose-built to power AI-enabled precision health solutions that accelerate research and improve care for individuals and communities. Uniquely positioned at the intersection of technology, data science, and healthcare, Verily transforms multimodal health data into insights, models, and actions that make healthcare more personalized, predictive, and precise.
Description
The Regulatory Compliance Lead is a technically grounded individual contributor responsible for developing and maintaining fit-for-purpose regulatory compliance frameworks across consumer, research, and medical device (SaMD) product areas. This role partners closely with engineering and product teams to operationalize US regulatory requirements - with an eye toward ex-US expansion - leveraging tools such as Jira, GitHub, and document control systems to embed compliance into the product development lifecycle.
Responsibilities
  • Develops and maintains fit-for-purpose regulatory compliance frameworks for consumer, research, and SaMD products, including AI/ML-enabled and generative AI applications, in alignment with applicable US regulations and with an eye toward ex-US expansion.
  • Partners with engineering, product, and quality teams to operationalize regulatory requirements throughout the product development lifecycle, leveraging Google Workspace, Jira, GitHub, and document control systems for change control, submission tracking, and compliance workflows.
  • Applies statistical methods and analytical tools to support regulatory decision-making, including performance evaluation, clinical equivalence assessments, and threshold analysis for regulated products. Supports post-market regulatory activities for AI/ML-enabled products, including real-world performance monitoring, algorithmic change assessment, post-market surveillance (PMS) planning, and evaluation of model drift or output degradation against predefined regulatory thresholds.
  • Conducts regulatory landscape assessments for new products and markets, identifying compliance risks and opportunities, and developing proactive mitigation strategies to maintain a strong regulatory posture. Monitors and interprets evolving regulatory guidance - including FDA SaMD, AI/ML, and predetermined change control plan (PCCP) frameworks - and translates requirements into actionable processes and procedures for cross-functional teams.
  • Authors and maintains regulatory documentation including submissions, SOPs, and Design and Development File content per ISO 13485:2016, supporting both pre-market and post-market compliance activities. Supports regulatory interactions and maintains awareness of agency expectations across applicable product domains; contributes to building positive relationships with regulatory bodies as Verily's product portfolio grows.

Qualifications
Minimum Qualifications
  • Bachelor's degree in engineering, computer science, statistics, or a related quantitative field with 5+ years of experience in regulatory affairs within the medical device, digital health, or life sciences industry.
  • Demonstrated technical experience developing regulatory compliance frameworks for SaMD and/or AI/ML-enabled products, with working knowledge of applicable FDA guidance including FDA QMSR, and familiarity with ISO 13485:2016 requirements, risk management processes per ISO 14971 and medical device software lifecycle processes per IEC 62304.
  • Proficiency with Google Workspace and software development and quality tools - including Jira, GitHub, and document control systems - with the ability to work directly within engineering workflows to operationalize compliance requirements.
  • Strong analytical and statistical skills with experience applying quantitative methods to regulatory evaluation, performance monitoring, or post-market surveillance activities.

Preferred Qualifications
  • Experience with AI/ML-enabled medical device products, including familiarity with FDA AI/ML SaMD guidance, predetermined change control plans (PCCP), and post-market performance monitoring for generative AI applications; experience using generative AI tools (e.g., Claude, ChatGPT) to enhance regulatory and compliance workflows is a plus.
  • Familiarity with MDSAP audit programs and/or international regulatory frameworks (e.g., EU MDR, Health Canada, TGA) in support of ex-US market expansion. Experience supporting regulatory compliance across regulated research programs, including GCP and/or GCLP environments, clinical studies, or laboratory-developed products.
  • Hands-on experience with post-market surveillance and vigilance activities for LLM or AI/ML-enabled products, including real-world performance monitoring, algorithmic change assessment, and predetermined change control plan (PCCP) implementation.
  • Experience applying statistical analysis tools (e.g., Python, R, or equivalent) to regulatory datasets, including performance benchmarking, signal detection, or equivalence testing in a regulated product context.
  • Advanced degree (MS, PhD) in engineering, statistics, computer science, or a related quantitative field, or a recognized regulatory certification such as RAC (US or EU).

Qualified applicants must not require employer sponsored work authorization now or in the future for employment in the United States.
The US base salary range for this full-time position is $111,000 - $167,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Verily Health Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here.
If you have a need that requires accommodation, please let us know by completing our Accommodations for Applicants form.

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