International Regulatory Affairs Specialist
$75,800–$121,300 year
On-site · Sparks, Maryland, United States
Job Summary
The International Regulatory Affairs Specialist coordinates and leads international product registrations, interpreting ex-U.S. regulations and assembling technical information into dossiers for submission. Responsibilities include coordinating inputs from R&D, Manufacturing, QA, and Marketing; interfacing with OEMs; acting as country lead for identified registrations; and proposing process improvements. The role requires a bachelor’s degree in regulatory affairs or a related scientific field, 2–5 years of regulatory affairs experience (RAC preferred), understanding of global regulatory submission processes (EU MDR/IVDR, Canada, LATAM, APAC), experience compiling technical documentation, and strong cross-functional collaboration and communication skills. Proficiency with SOPs, QA systems (ISO 13485), and Microsoft Office is expected, with the ability to manage multiple submissions simultaneously. The position emphasizes on-site work in the USA (MD – Sparks) with potential remote/field-based arrangements indicated per location policy.
Required Qualifications
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline
- Minimum 2–5 years of regulatory affairs experience (preferably in medical devices, pharmaceuticals, or healthcare products)
- Regulatory Affairs Certification (RAC) preferred
- Experience coordinating cross-functional inputs (R&D, QA, Manufacturing, Marketing)
- Ability to compile and review technical documentation per country-specific requirements
- Understanding of regulatory submission processes and lifecycle management
- Strong written and verbal communication skills
- Experience working with global teams or distributors
- Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
- Knowledge of global regulatory requirements (EU MDR/IVDR, Canada, LATAM, APAC)
- Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)
- Ability to manage multiple submissions/projects simultaneously
- Strong organizational skills
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