Job Description

Job Title: Regulatory Affairs Coordinator (Entry-Level)

Location: N/A; Remote

Full-Time | Early Career Opportunity (0-2 years of experience)

About the Role

The Regulatory Affairs Coordinator plays a key role in supporting the fulfillment of documentation required for global regulatory submissions. This position is responsible for identifying, retrieving, and organizing regulatory documents from internal systems to support local country teams as they manage product registrations, renewals, and related regulatory activities. The role ensures timely access to accurate documentation throughout the product lifecycle for a global medical device leader.

Key Responsibilities

Depending on your assignment within the RA Fulfillment team, you may:

Search, retrieve, and organize technical and regulatory documents from internal systems (e.g., quality management systems, PLM, MDRiM, GRID).
Support local regulatory teams around the world by preparing documentation packages for registration, renewal, or tender activities.
Help maintain document traceability and version control throughout the product lifecycle.
Upload and manage data in regulatory systems to ensure alignment with internal records and regulatory requirements.
Communicate with internal stakeholders to resolve documentation gaps or follow-ups.
Follow established standard operating procedures (SOPs) to ensure quality and compliance in documentation processes.
Minimum Qualifications

Bachelor's degree in Life Sciences, Engineering, or a related field.
Internship or co-op experience in a regulated industry (medical device, pharma, biotech, etc.) or at least 6 months of work experience in a regulated environment.
Strong attention to detail and ability to work with structured documentation.
Comfortable navigating digital systems and working with large volumes of data.
Excellent organizational and communication skills.
Written and verbal fluency in English and Spanish.
Preferred Qualifications

Familiarity with regulatory terminology or product registration processes.
Exposure to FDA or ISO-regulated environments.
Experience using platforms such as PLM, MDRiM, or other quality/regulatory document systems

Job Types: Full-time, Contract

Work Location: Remote