Regulatory Affairs Specialist
$60,000–$80,000 year
Remote · United States or Ames, Iowa, United States
Job Summary
Regulatory Affairs Specialist supporting day-to-day regulatory activities for Henry Schein One’s dental imaging software (SaMD). Responsibilities include assisting with regulatory submissions and correspondence, maintaining technical files aligned with FDA guidance and EU MDR requirements, preparing pre-submission materials, supporting QMS documentation, CAPA and risk management, regulatory intelligence across US/EU/UK/CA/AU, liaising with product/QA/legal/IT, ensuring marketing claims meet regulatory requirements, and supporting post-market activities including adverse event reporting and privacy/compliance tasks. Travel typically minimal. Requires Bachelor’s in a related field and 1-3 years in regulatory affairs; familiarity with FDA SaMD pathways and international regulatory frameworks; strong written/verbal communication and cross-functional collaboration skills.
Required Qualifications
- 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
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