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Samd Regulatory Jobs in Ridgewood, NJ (NOW HIRING)

Norbert Health

Applied AI Engineer

New York, NY · On-site

You'll work across cloud and edge deployments, and some of the systems you'll touch are on a SaMD pathway, so you'll need to be comfortable shipping under regulatory constraints. What you'll do

Norbert Health

Applied AI Engineer

Brooklyn, NY · On-site

You'll work across cloud and edge deployments, and some of the systems you'll touch are on a SaMD pathway, so you'll need to be comfortable shipping under regulatory constraints. What you'll do

Norbert Health

Applied AI Engineer

Brooklyn, NY

You'll work across cloud and edge deployments, and some of the systems you'll touch are on a SaMD pathway, so you'll need to be comfortable shipping under regulatory constraints. What you'll do

All JobsSamd Regulatory JobsSamd Regulatory Jobs in Ridgewood, NJ

Samd Regulatory information

See Ridgewood, NJ salary details

$41K

$96.5K

$140.1K

How much do samd regulatory jobs pay per year?

As of Sep 14, 2026, the average yearly pay for samd regulatory in Ridgewood, NJ is $96,536.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,400.00 and $113,300.00 per year, depending on experience, location, and employer.

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.

Samd Regulatory jobs near you
Infographic showing various Samd Regulatory job openings in Ridgewood, NJ as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 83% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution, with an average salary of $96,536 per year, or $46.4 per hour.

Regional Regulatory Affairs Lead, US

New York, NY • On-site

Neko Health AB
See more jobs at Neko Health ABexternal

$191K - $233K/yr

Full-time

Re-posted 28 days ago

Job description

Mission
Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear.
In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.
As we grow in the US, we're looking for a regulatory leader to build our regulatory function from the ground up. You'll set the strategy, shape the day-to-day, and clear the path for our devices in the world's biggest medical device market.
About the role
This is our first regulatory affairs hire in North America. You'll build the US RA function from the ground up, manage our relationship with the FDA (including device submissions), and hold the statutory roles of US Agent, Initial Importer, and Medical Device Distributor. Working with the Director of Regulatory Affairs, you'll help shape Neko's global regulatory strategy and bring the US perspective to the table.
Where you'll make an impact
  • Set up the US RA function: core processes, SOPs, and a live, in-region quality management system, working closely with the Quality team.
  • Manage our relationship with FDA, including device submissions, and guide the implementation of the regulatory pathway for the US device portfolio.
  • Build a scalable, state-by-state expansion process and be the voice of the US market in Neko's regulatory planning.
  • Hold the US Agent, Initial Importer, and Medical Device Distributor roles, and manage post-market regulatory activity for the region.
  • Help shape both the US and global RA strategy and define what the future US team looks like.

What you'll bring
  • 8+ years in medical device regulatory affairs, with at least 5 focused on FDA-regulated devices.
  • A track record as the accountable lead on US clearances or approvals: 510(k), De Novo, or PMA.
  • Direct FDA engagement: you've planned and led pre-submission and submission meetings.
  • Eligibility and willingness to hold the US Agent, Initial Importer, and Medical Device Distributor roles.
  • Experience building processes, SOPs, or teams in a scale-up or greenfield setting, not just working within an established one.
  • Experience supporting clinical expansion into new markets or sites.
  • A solid grasp of the operations behind that expansion - from in-region setup to scaling day-to-day delivery.
  • Hands-on experience using AI for regulatory and market intelligence, documentation preparation, and workflow automation - with the judgement to distinguish what to automate from what requires expert oversight.
  • A degree in a relevant field.

Nice to have
  • Software as a Medical Device (SaMD) experience alongside a hardware device background.
  • Experience partnering with product development in medtech or healthtech engineering.
  • Experience building or scaling a regional regulatory team.

Why Neko
At Neko, you'll get a rare chance to build a regulatory function from the ground up, at a company that believes preventive healthcare can change lives. The package is competitive - base salary, equity, and full benefits - but the real draw is the work itself: a world-class team, and watching what you build reach members across two continents.
  • Build something lasting: create the US RA function from scratch - the processes, the team, and how the work gets done locally.
  • A voice in global RA: a genuine say in regulatory decisions from day one, portfolio strategy included.
  • Real ownership of the US market: backed by a global RA framework that gives you strong support, not a blank check.
  • Strategy and hands-on depth: big-picture direction and day-to-day technical work in the same role.
  • An experienced team beside you: a seasoned RA and Quality team to lean on.

Apply