International Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Collaborates with colleagues across regions to formulate strategies for moderately complex submissions to regulatory agencies globally.

• Analyzes regulations and guidance from outside the U.S. and conveys their implications for registration.

• Coordinates and facilitates product registration requests on a worldwide scale.

• Engages with global regulatory and marketing teams to assist with regional registration needs.

• Develops and maintains departmental procedures for international product registrations.

• Compiles technical information in accordance with registration standards.

• Identifies and suggests ongoing process enhancements.

⛳️ Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or a related scientific/technical field.

• Experience in coordinating inputs from various functions (R&D, QA, Manufacturing, Marketing).

• Capacity to compile and review technical documents in line with country-specific requirements.

• Knowledge of regulatory submission processes and lifecycle management.

• Excellent written and verbal communication abilities.

• Experience collaborating with global teams, regional affiliates, or distributors.

• Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485).

• Strong organizational skills with the ability to manage multiple submissions and projects at once.

• Proficient in Microsoft Office applications (Excel, Word, PowerPoint).

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options