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Entry Level Remote Regulatory Affairs Jobs (NOW HIRING)

Henry Schein One

Regulatory Affairs Specialist

Ames, IA · On-site +1

$60K - $80K/yr

This position can be remote within the United States or hybrid 2-3 days per week in Ames, IA Job ... Bachelor's degree in life sciences, engineering, regulatory affairs, or related field or equivalent ...

Henry Schein One

Regulatory Affairs Specialist

Ames, IA · Remote

This position can be remote within the United States or hybrid 2-3 days per week in Ames, IA Job ... Bachelor's degree in life sciences, engineering, regulatory affairs, or related field or equivalent ...

Getinge

Regulatory Affairs Specialist I

Fraser, MI · Remote

Ability to represent Regulatory Affairs to other departments. * Working knowledge of principle ... LI-Remote About us With a firm belief that every person and community should have access to the ...

MEDVACON

Medical Affairs Manager [515]

Foster City, CA · On-site +1

... regulatory agency inspections * Supports Medical Affairs with internal or external routine audit activities and document reviews. * Ability to work hybrid if local to the site only - NO Full remote ...

Air Force Civilian Career Training

$49K - $115K/yr

... perform entry-level assignments in work associated with advising or performing research in ... The Federal Travel Regulation Bulletin (FTR) 18-05 issued by General Services Administration (GSA ...

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Entry Level Remote Regulatory Affairs information

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How much do entry level remote regulatory affairs jobs pay per hour?

As of Jun 17, 2026, the average hourly pay for entry level remote regulatory affairs in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What is the difference between Entry Level Remote Regulatory Affairs vs Entry Level Remote Quality Assurance?

AspectEntry Level Remote Regulatory AffairsEntry Level Remote Quality Assurance
Required CredentialsBachelor's in life sciences, certifications like RAC (preferred but not always required)Bachelor's in related fields, certifications like CQE (optional)
Work EnvironmentRemote, often in pharmaceutical, biotech, or medical device companiesRemote or on-site, in manufacturing or healthcare industries
Employer & Industry UsageRegulatory agencies, pharmaceutical, biotech, medical device companiesManufacturing, healthcare, and product companies

Entry Level Remote Regulatory Affairs focuses on ensuring products meet regulatory standards, requiring knowledge of regulations and documentation. Entry Level Remote Quality Assurance emphasizes product quality and compliance, often involving inspections and process audits. Both roles are remote, entry-level, and industry-specific, but they serve different functions within product development and compliance.

More about Entry Level Remote Regulatory Affairs jobs
What cities are hiring for Entry Level Remote Regulatory Affairs jobs? Cities with the most Entry Level Remote Regulatory Affairs job openings:
What are the most commonly searched types of Remote Regulatory Affairs jobs? The most popular types of Remote Regulatory Affairs jobs are:
What states have the most Entry Level Remote Regulatory Affairs jobs? States with the most job openings for Entry Level Remote Regulatory Affairs jobs include:
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Entry Level Remote Regulatory Affairs jobs near you
Infographic showing various Entry Level Remote Regulatory Affairs job openings in the United States as of June 2026, with employment types broken down into 90% Full Time, and 10% Part Time. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Henry Schein One

Ames, IA • On-site, Remote

$60K - $80K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 6 days ago

Job description

This position can be remote within the United States or hybrid 2-3 days per week in Ames, IA
Job Summary
This position is responsible for the day-to-day regulatory activities for Henry Schein One's dental imaging software (SaMD). In this role, you will assist with documentation, updating technical files, preparing submissions, and maintaining parts of the quality system, for software and digital health products.
What You Will Do
  • Regulatory submissions support
    • Assist with regulatory submissions and correspondence under the guidance of the Regulatory Manager (e.g., prepare submission packages, compile evidence packages, organize and track submission milestones).
    • Support international regulatory submissions, including EU MDR technical documentation, UKCA submissions, Australian TGA registrations, and Canadian licensing activities.
    • Help maintain technical documentation in alignment with FDA guidance, EU MDR requirements, and other global regulatory expectations.
    • Prepare materials for pre submission activities (e.g., FDA Q Sub, EU MDR consultations, international authority inquiries)..
  • Quality systems and compliance support
    • Maintain and update QMS documentation under supervision; support design controls, change control, CAPA tracking, and supplier qualification processes.
    • Ensure alignment with primary medical device standards, including:
      • EU MDR 2017/745
      • EN ISO 13485 (Quality Management Systems)
      • ISO 14971 (Risk Management)
      • IEC 62304:2006 / Amd 1:2015 (Medical Device Software - Software Life Cycle Processes)
    • Assist with internal audits preparation and follow-up actions; help maintain risk management artifacts in support of product development.
  • Regulatory intelligence and cross-functional support
    • Monitor regulatory developments across the US, EU, UK, AU, and CA and emerging markets such as Italy, Austria, and Spain affecting dental imaging software and SaMD; summarize implications for product teams.
    • Serve as a light-touch regulatory liaison to Product, Software, QA, Legal, and IT/Security, escalating questions as needed.
  • Advertising and claims support
    • Ensure marketing claims are aligned with regulatory requirements; escalate potential issues.
  • Post-market activities
    • Support post-market surveillance activities, including intake of complaints and basic adverse event reporting processes (e.g., MedWatch coordination with senior staff, EU vigilance support, international reporting workflows).
    • Track and assist with CAPA activities related to post-market findings.
    • Privacy, data security, and PHI compliance
    • Assist with HIPAA/privacy considerations and data handling guidelines for cloud-based imaging workflows; support vendor risk assessments and data protection tasks.
  • Documentation and training
    • Create, organize, and maintain regulatory templates, checklists, and quick-reference guides.
    • Help develop training materials for internal teams on regulatory requirements and processes.
  • Geographic scope management
    • Support regulatory requirements and product configurations for the US, EU, UK, Australia, and Canada.
    • Coordinate with external consultants as needed for international submissions and compliance activities.
Travel/Physical Demands
  • Travel typically less than 10%
  • Office environment with no special physical demands required
Qualifications
What You Will Have
  • Bachelor's degree in life sciences, engineering, regulatory affairs, or related field or equivalent experience
  • 1-3 years of regulatory affairs or related experience (internships/co-ops acceptable)
  • Familiarity with US FDA pathways for SaMD (potential 510(k) or De Novo) and 21 CFR Part 820; exposure to 21 CFR Part 11 is a plus.
  • Familiarity with regulatory frameworks in EU (MDR), UK (UKCA), Canada (Health Canada), and Australia (TGA).
  • Basic understanding of FDA SaMD guidance, software validation, and cybersecurity concepts.
  • Basic familiarity with QMS elements, CAPA, design controls, and risk management per ISO 14971.
  • Proficiency with Microsoft Office.
  • Ability to develop templates, checklists, and training materials.
  • Strong written and verbal communication, attention to detail, and ability to collaborate cross-functionally.
  • Self-motivated, organized, and able to manage multiple small projects with supervision.
Nice to Haves
  • Regulated industry experience
  • Exposure to IEC 62304 and ISO 13485
  • Experience with electronic document management systems (e.g., eQMS)
  • RAC is not required but encouraged; pursuing RAC is a plus.
The posted range for this position is $60,000 - $80,000 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc. This position is eligible for a bonus target not reflected in the range.
What you get as a Henry Schein One Employee
  • A great place to work with fantastic people
  • A career in the healthcare technology industry, with the ability to grow and realize your full potential
  • Competitive compensation
  • Excellent benefits package - Medical, Dental and Vision Coverage, 401K Plan with Company Match, Paid Time Off (PTO), Sick Leave (if applicable), Paid Parental Leave, Short Term Disability, Income Protection, Work Life Assistance Program, Health Savings and Flexible Spending Accounts, Education Benefits, Worldwide Scholarship Program, Volunteer Opportunities, and more
About Henry Schein One
Henry Schein Oneis the global leader in dental management, analytics, communication, and marketing software. Our company's products and services work together as one simple solution to provide users with a seamless and integrated experience.
Our company thrives because of our people. We believe in supportive, diverse, and inclusive workforce, inclusive environments, professional development opportunities, and competitive compensation packages. We value innovation, teamwork, and encourage work-life balance.
One of many reasons why Henry Schein One leads the industry is because of our products, services and most importantly, our people.
In 2022, Henry Schein One was named one of Best Companies to Work for in Utah. Click here for more information: 2022 Best Companies to Work For | Henry Schein One
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Unfortunately, Henry Schein One is not currently hiring individuals residing in Alaska, Delaware, Hawaii, Louisiana, Nebraska, North Dakota, Rhode Island, South Dakota, Vermont, West Virginia, Washington DC, or Puerto Rico and other US Territories.

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