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Samd Regulatory Jobs (NOW HIRING)

Senior Program Manager, SaMD

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 ...

Senior Program Manager, SaMD

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 ...

Senior Program Manager, SaMD

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 ...

Senior Program Manager, SaMD

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 ...

Director, Clinical Science

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 ...

Director, Clinical Science

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 ...

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 ...

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

Director, Clinical Science

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 ...

Senior Program Manager, SaMD

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 ...

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

Director, Clinical Science

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 ...

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Samd Regulatory information

See salary details

$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.
More about Samd Regulatory jobs
What cities are hiring for Samd Regulatory jobs? Cities with the most Samd Regulatory job openings:
What states have the most Samd Regulatory jobs? States with the most job openings for Samd Regulatory jobs include:
Senior Product Owner, Digital Health--SaMD (Remote)

Senior Product Owner, Digital Health--SaMD (Remote)

Bausch + Lomb

Denver, CO • Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday

New


Bausch & Lomb rating

8.6

Company rating: 8.6 out of 10

Based on 39 frontline employees who took The Breakroom Quiz

28th of 527 rated manufacturers


Job description

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 DO
  • Set a clear and ambitious product vision and communicate it effectively to the team and B+L leadership
  • Champion the MVP mindset, distilling the product at every stage to what is desirable, viable, and feasible, and protecting the team from scope creep
  • Own the product roadmap end to end, from discovery through delivery, making hard prioritization calls with speed and confidence, and ensuring every decision is grounded in real clinical workflows
  • Build deep relationships with eye care providers, patients, and clinic staff, running structured feedback loops and translating insight into clear product priorities and a well‑groomed backlog
  • Own the end‑to‑end patient and eye care provider experience, partnering with UX and design to ensure every touchpoint is intuitive and clinically appropriate
  • Lead vendor and partner evaluation, selection, and onboarding for core technology components
  • 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 reviews and user testing to validate that what ships works for patients and staff
  • Instrument the product from day one, define the KPIs that matter to clinics, and translate clinical and commercial data into clear, actionable recommendations for B+L leadership
  • Develop an informed perspective on reimbursement and payer strategy, including the CPT code landscape and value‑based care models
  • Help define and shape how the digital health platform scales across B+L's surgical, pharmaceutical, vision care, and consumer businesses over time
  • Hire and build a product team as the organization scales from pilot to platform
WHAT WE ARE LOOKING FOR REQUIRED
  • 8+ years of product management experience, including at least one role where you owned a full product from zero to launch; background in clinical, regulated, or complex healthcare‑adjacent environments strongly preferred
  • Experience with AI‑powered or conversational patient‑facing digital health products
  • Track record of building with and for clinicians surgeons, physicians, or clinical staff not just for them
  • Strong commercial instinct: you think about ROI and adoption as much as you think about features
  • Experience operating in a fast‑moving, resource‑constrained environment startup, growth‑stage, or independent unit inside a larger company
  • Comfortable with ambiguity and capable of making confident decisions with incomplete information
  • Sufficient technical fluency to evaluate architecture tradeoffs, work productively with engineering teams, and make informed decisions on AI and data infrastructure
STRONGLY PREFERRED
  • Background in ophthalmology, surgical specialty software, or ophthalmic devices
  • Familiarity with FDA regulatory pathways for Software as a Medical Device (SaMD) or 510(k)
  • Experience with HIPAA compliance, BAA frameworks, and healthcare data governance
  • Prior experience at a company in the digital health or medtech space

This 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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About Bausch & Lomb

Sourced by ZipRecruiter

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.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Bridgewater, NJ, US

Year founded

1853