Regulatory Affairs Specialist

Henry Schein One•Ames, IA

1d•Hybrid

About The Position

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.

Requirements

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.

Responsibilities

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).
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.
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.
Ensure marketing claims are aligned with regulatory requirements; escalate potential issues.
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.
Assist with HIPAA/privacy considerations and data handling guidelines for cloud-based imaging workflows; support vendor risk assessments and data protection tasks.
Create, organize, and maintain regulatory templates, checklists, and quick-reference guides.
Help develop training materials for internal teams on regulatory requirements and processes.
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.