The Role
Responsible for regulatory activities related to dental imaging software, including submissions, compliance support, and maintaining technical documentation. Collaborates with cross-functional teams and monitors regulatory developments across multiple regions.
Summary Generated by Built In
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
What You Will Have
What you get as a Henry Schein One Employee
Henry Schein One is 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.
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 typically less than 10%
- Office environment with no special physical demands required
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.
- 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.
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
Henry Schein One is 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.
Skills Required
- Bachelor's degree in life sciences, engineering, regulatory affairs, or related field
- 1-3 years of regulatory affairs or related experience
- Familiarity with US FDA pathways for SaMD
- Familiarity with regulatory frameworks in EU, UK, Canada, and Australia
- Basic understanding of FDA SaMD guidance and software validation
- Basic familiarity with QMS elements, CAPA, and risk management
- Proficiency with Microsoft Office
- Strong written and verbal communication skills
- Ability to develop templates and training materials
Henry Schein One Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Henry Schein One and has not been reviewed or approved by Henry Schein One.
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Leave & Time Off Breadth — Unlimited PTO and generous vacation allowances are frequently highlighted, supporting strong work–life balance. Paid holidays and flexible time-off norms further enhance the time-away experience.
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Retirement Support — 401(k) matching is considered a standout element of the package, adding meaningful long‑term value. Retirement benefits are often viewed as a key offset when base pay feels modest.
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Healthcare Strength — Health plans are commonly described as good and comprehensive. Access to supportive programs and coverage breadth contributes to overall benefits satisfaction.
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The Company
What We Do
Henry Schein One is the world’s largest dental practice management software company. Founded in 2018, Henry Schein One launched a new era of integrated dental technology by merging the market-leading practice management, patient communication and marketing systems of Henry Schein and Internet Brands into one company. Our goal: To simplify each aspect of dental practice management by delivering software that connects with each other, shares data and automates more tasks – helping each member of the dental team work smarter and more efficiently. Headquartered in American Fork, Utah, Henry Schein One combines market-leading brands, such as Dentrix®, Dentrix Ascend®, Lighthouse360®, and TechCentral™, as well as Henry Schein's international dental practice management systems, including Software of Excellence®, Logiciel Julie, InfoMed®, Exan®, and Labnet™, with the dental businesses of Internet Brands, including web-based solutions such as Demandforce®, Sesame Communications®, Officite®, and DentalPlans.com® and more. Henry Schein One integrated 13 companies, 40+ software brands and employs approximately 1,500 people.
