Regulatory Affairs Specialist (Medtech)

TL;DR

Regulatory Affairs Specialist (Medtech): Managing day-to-day regulatory activities for dental imaging software (SaMD) with an accent on regulatory submissions, technical documentation, and QMS maintenance. Focus on ensuring compliance with FDA, EU MDR, and other global regulatory frameworks for digital health products.

Location: Remote within the United States or hybrid in Ames, IA. Not hiring in AK, DE, HI, LA, NE, ND, RI, SD, VT, WV, DC, or PR.

Salary: $60,000 - $80,000

Company

Global leader in dental management, analytics, communication, and marketing software.

What you will do

• Support regulatory submissions and correspondence for FDA, EU MDR, UKCA, TGA, and Health Canada.
• Maintain QMS documentation, including design controls, CAPA tracking, and supplier qualification processes.
• Monitor global regulatory developments affecting SaMD and summarize implications for product teams.
• Review marketing claims to ensure alignment with regulatory requirements.
• Coordinate post-market surveillance, including intake of complaints and adverse event reporting.
• Assist with HIPAA/privacy considerations and data handling guidelines for cloud-based imaging workflows.

Requirements

• Bachelor’s degree in life sciences, engineering, regulatory affairs, or equivalent experience.
• 1-3 years of regulatory affairs or related experience.
• Familiarity with US FDA pathways for SaMD (510(k) or De Novo) and 21 CFR Part 820.
• Knowledge of regulatory frameworks in EU (MDR), UK (UKCA), Canada, and Australia (TGA).
• Basic understanding of ISO 14971, software validation, and cybersecurity concepts.
• Must be based in the United States (excluding the mentioned restricted states/territories).

Nice to have

• Experience with IEC 62304 and ISO 13485.
• Experience with electronic document management systems (eQMS).
• Pursuing or holding a RAC certification.

Culture & Benefits

• Medical, Dental, and Vision Coverage.
• 401K Plan with Company Match.
• Paid Time Off (PTO), Sick Leave, and Paid Parental Leave.
• Health Savings and Flexible Spending Accounts (HSA/FSA).
• Education Benefits and Worldwide Scholarship Program.
• Supportive, diverse, and inclusive work environment.