Samd Regulatory Jobs (NOW HIRING)

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 ...

... SaMD regulatory and authorization requirements, and milestone-driven program design. They will lead the full range of technical activities required to conceptualize, prepare, and deliver grant ...

Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...

Partner with the CTO on architecture, data governance, AI model decisions, and FDA cybersecurity guidance in support of a future SaMD regulatory pathway * Drive fast iteration cycles, using design ...

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 ...

JOB PURPOSE: · Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. · Serve as regulatory lead for novel oncology ...

Partner with the CTO on architecture, data governance, AI model decisions, and FDA cybersecurity guidance in support of a future SaMD regulatory pathway * Drive fast iteration cycles, using design ...

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 ...

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 ...

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 ...

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 ...

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 ...

Lead regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance * Preparing international and domestic regulatory ...

As we expand into new areas of digital health and Software as a Medical Device (SaMD), we are ... WHOOP is seeking a Staff Regulatory Affairs Associate to help shape the regulatory strategy for ...

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 ...

Lead and execute regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly authoring technical documentation and managing ...

Lead and execute regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly authoring technical documentation and managing ...

Lead and execute regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly authoring technical documentation and managing ...

Submission Leadership (AI/ML SaMD): Lead the planning, authorship, and submission of regulatory filings (510(k), De Novo, Q-Submissions) for AI/ML-enabled software. You will be the primary author ...

The Opportunity This role covers both medical device hardware and Class II SaMD (software as a medical device) . You will take full ownership of regulatory and quality operations across the U.S ...