Note: The job is a remote job and is open to candidates in USA. Henry Schein One is the global leader in dental management, analytics, communication, and marketing software. They are seeking a Regulatory Affairs Specialist to manage day-to-day regulatory activities for dental imaging software, including regulatory submissions, quality systems support, and compliance activities.
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
Skills
- 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
Benefits
- Bonus target not reflected in the range
- 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
Company Overview
Henry Schein One is the world's largest dental practice management software company. It was founded in 2018, and is headquartered in American Fork, Utah, USA, with a workforce of 1001-5000 employees. Its website is http://www.henryscheinone.com/.