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 ...
New
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 ...
New
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 ...
New
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 ...
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 ...
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 ...
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 ...
Hippocratic AI in Palo Alto is seeking a Head of Regulatory Affairs to lead global regulatory strategies for AI-driven SaMD and medical products. The role requires overseeing compliance, managing ...
Hippocratic AI in Palo Alto is seeking a Head of Regulatory Affairs to lead global regulatory strategies for AI-driven SaMD and medical products. The role requires overseeing compliance, managing ...
... 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 ...
... 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 ...
Boston, MA · On-site
$126K - $126K/yr
Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...
Boston, MA · On-site
$126K - $126K/yr
Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...
Boston, MA · On-site
$126K - $126K/yr
Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...
Boston, MA · On-site
$126K - $126K/yr
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 ...
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 ...
Boston, MA · On-site
$126K - $126K/yr
Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...
Boston, MA · On-site
$126K - $126K/yr
Responsibilities : • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch • Partner with Machine Learning, Product ...
Boston, MA · On-site
$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 ...
Boston, MA · On-site
$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 ...
Laguna Hills, CA · On-site
$90K - $140K/yr
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 ...
Quick apply
Laguna Hills, CA · On-site
$90K - $140K/yr
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 ...
Boston, MA · On-site
$86K - $118K/yr
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 ...
Boston, MA · On-site
$86K - $118K/yr
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 ...
Boston, MA · On-site +1
$86K - $118K/yr
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 ...
Boston, MA · On-site +1
$86K - $118K/yr
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 ...
OR · On-site
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 ...
OR · On-site
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 ...
OR · On-site +1
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 ...
OR · On-site +1
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 ...
Madison, WI · On-site
Regulatory & compliance (SaMD) - regulatory adherence, QMS integration and cross function collaboration. About EnsoData EnsoData strives to make healthcare more accurate, efficient, and affordable ...
Madison, WI · On-site
Regulatory & compliance (SaMD) - regulatory adherence, QMS integration and cross function collaboration. About EnsoData EnsoData strives to make healthcare more accurate, efficient, and affordable ...
Boston, MA · On-site
$86K - $118K/yr
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 ...
Boston, MA · On-site
$86K - $118K/yr
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 ...
Boston, MA · On-site
$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 ...
Boston, MA · On-site
$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 ...
Madison, WI · On-site
Regulatory & compliance (SaMD) - regulatory adherence, QMS integration and cross function collaboration. About EnsoData EnsoData strives to make healthcare more accurate, efficient, and affordable ...
Quick apply
Madison, WI · On-site
Regulatory & compliance (SaMD) - regulatory adherence, QMS integration and cross function collaboration. About EnsoData EnsoData strives to make healthcare more accurate, efficient, and affordable ...
Boston, MA · On-site +1
$86K - $118K/yr
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 ...
Quick apply
Boston, MA · On-site +1
$86K - $118K/yr
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 ...
$40.5K - $49.4K
2% of jobs
$49.4K - $58.3K
7% of jobs
$58.3K - $67.2K
7% of jobs
$74.9K is the 25th percentile. Wages below this are outliers.
$67.2K - $76.1K
9% of jobs
$76.1K - $85K
12% of jobs
The median wage is $92.4K / yr.
$85K - $94K
15% of jobs
$94K - $102.9K
16% of jobs
$109.8K is the 75th percentile. Wages above this are outliers.
$102.9K - $111.8K
8% of jobs
$111.8K - $120.7K
11% of jobs
$120.7K - $129.6K
2% of jobs
$129.6K - $138.5K
11% of jobs
$40.5K
$95.4K
$138.5K
| 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.
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted yesterday
New
8.6
Based on 39 frontline employees who took The Breakroom Quiz
28th of 527 rated manufacturers
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
As Product Owner Digital Health Services, you will be among the first and most critical hires on the team. You will report to the President, Digital Health Services. You will be responsible for engaging with eye care providers and patients to understand what problems to solve, decide what to build, own the roadmap, and make sure the product delivers measurable outcomes in clinics. You will be joining a small founding team of product, engineering, clinical, and commercial leaders who are built for speed, not process.
The initial focus will be on transforming how patients experience and navigate ophthalmic care, starting in the surgical setting and proving measurable clinical and commercial impact. From there, the platform ambition spans the full B+L portfolio, covering surgical, pharmaceutical, vision care, and consumer, including building toward a Software as a Medical Device (SaMD) regulatory pathway.
WHAT YOU WILL DOThis position may be available in the following location(s): US‑Remote
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $225,000 - $260,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short‑term and/or long‑term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement. Our Benefit Programs: Employee Benefits: Bausch + Lomb
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world--from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Medical equipment and supplies manufacturing
10,000+ Employees
Bridgewater, NJ, US
1853