[Remote] Regulatory Affairs Specialist

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