Program Manager Samd
Mountain View, CA · On-site
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 ...
Program Manager Samd
Mountain View, CA · On-site
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 ...
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 ...
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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 ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety * Ensure compliance with applicable ...
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 ...
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 ...
Director, Global Regulatory Affairs & Intelligence
Emeryville, CA · On-site
$190 - $270/hr
The Director owns the overall regulatory strategy for the company and drives highly coordinated submissions and approvals (FDA, CE Mark, Health Canada, PMDA, etc.) for our SaMD and hardware portfolio ...
Director, Global Regulatory Affairs & Intelligence
Emeryville, CA · On-site
$190 - $270/hr
The Director owns the overall regulatory strategy for the company and drives highly coordinated submissions and approvals (FDA, CE Mark, Health Canada, PMDA, etc.) for our SaMD and hardware portfolio ...
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 ...
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 ...
Staff Regulatory Affairs Engineer
San Francisco, CA · On-site
$168K - $252K/yr
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 ...
Staff Regulatory Affairs Engineer
San Francisco, CA · On-site
$168K - $252K/yr
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 ...
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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 ...
Head of Quality Engineering & Regulatory Affairs
Menlo Park, CA · On-site +1
$176K - $233K/yr
The role owns the quality and regulatory strategy that enables global commercialization of AI/ML SaMD products and serves as both Management Representative (MR) and Person Responsible for Regulatory ...
Quick apply
Head of Quality Engineering & Regulatory Affairs
Menlo Park, CA · On-site +1
$176K - $233K/yr
The role owns the quality and regulatory strategy that enables global commercialization of AI/ML SaMD products and serves as both Management Representative (MR) and Person Responsible for Regulatory ...
Sr Regulatory Affairs Specialist
San Diego, CA · On-site +1
Your experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to effectively advise on regulatory ...
Sr Regulatory Affairs Specialist
San Diego, CA · On-site +1
Your experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to effectively advise on regulatory ...
Director Clinical Affairs
Santa Clara, CA · On-site
$174K - $230K/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 ...
Director Clinical Affairs
Santa Clara, CA · On-site
$174K - $230K/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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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?
| Aspect | Samd Regulatory | Samd Quality Assurance |
|---|---|---|
| Certifications | Regulatory Affairs Certification (RAC), FDA, ISO | ISO 9001, Six Sigma, Quality Auditor |
| Work Environment | Regulatory agencies, compliance departments | Manufacturing, product testing, quality departments |
| Industry Usage | Pharmaceuticals, medical devices, biotech | Manufacturing, 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 popular job titles related to Samd Regulatory jobs in California?
For Samd Regulatory jobs in California, the most frequently searched job titles are:
- Rac Regulatory Affairs Certification
- Regulatory Affairs Pharmacist
- Regulatory Affairs Specialist Remote
- Remote Ectd Publisher
- Remote Regulatory Submission Publisher
- Regulatory Affairs Advertising Promotions
- Freelance Regulatory Affairs Consultant
- Assistant Ectd Publisher
- Associate Director Regulatory Affairs
- Regulatory Submissions Manager
What job categories do people searching Samd Regulatory jobs in California look for?
The top searched job categories for Samd Regulatory jobs in California are:
- Regulatory Affairs Manager Biotech
- No Experience Regulatory Affairs
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What cities in California are hiring for Samd Regulatory jobs?
Cities in California with the most Samd Regulatory job openings:
Program Manager Samd
Mountain View, CA • On-site
Apex Informatics •
IT Services • 1 - 10 employees1 - 10 employees
Full-time
Re-posted yesterday
Job description
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 organizational and time management skills.
- Strong communication and interpersonal skills, with the ability to work effectively with diverse teams.
- Proficiency in project management tools and software.
- PMP certification or equivalent is preferred
- Strong knowledge of Software as a Medical Device (SAMD) regulations and standards.
- Excellent organizational and time management skills.
- Strong communication and interpersonal skills, with the ability to work effectively with diverse teams.
- Proficiency in project management tools and software.
- PMP certification or equivalent is preferred
About Apex Informatics
Sourced by ZipRecruiter
Industry
It services
Company size
1 - 10 Employees
Headquarters location
Omaha, NE, US
Year founded
2014