What are the responsibilities and job description for the Regulatory Specialist position at Medasource?
Regulatory Affairs Coordinator I
Location: Irvine, CA
Duration: 1 year contract
Education Requirement: Bachelor’s degree minimum
Experience: Regulatory support experience; international submission support preferred
Overview
The Regulatory Affairs Coordinator plays a key role in supporting the Surgical Vision regulatory organization by managing documentation, preparing routine submissions, and maintaining high-quality records across global regulatory teams. This position ensures processes remain consistent, documentation is compliant, and submissions move efficiently to meet strategic timelines and support ongoing product lifecycle needs.
Key Responsibilities
Regulatory Documentation & Submissions
- Prepare, dispatch, and file routine regulatory documentation.
- Collaborate with Regulatory Affairs team members to prioritize and prepare submission components and labeling updates.
- Edit, format, and finalize submission documents and labeling while following regulatory guidelines, internal procedures, and document design standards.
- Assist in publishing and packaging submission materials for health authorities.
Document Management & Systems Work
- Upload, archive, and maintain regulatory documents within electronic document management systems (e.g., QUMAS, Agile).
- Create and organize electronic structures for storage, including migrating existing documents into the proper system.
- Collect documents for import or creation within electronic storage and retrieval tools.
- Maintain consistency across templates and ensure documents follow company design standards.
Operational & Cross-Functional Support
- Support legalization and apostille processes for documents used in international submissions.
- Provide document authentication as a notary when required.
- Route documents through Quality Management Systems to ensure proper review and approval.
- Track and report metrics related
Process Improvement
- Help maintain and standardize processes across the region.
- Collaborate with global team members to support consistent documentation practices across all markets.
Preferred Qualifications
- Bachelor’s degree required.
- Experience supporting international submissions is preferred.
- Strong attention to detail and excellent document formatting skills.
- Familiarity with regulatory publishing tools and electronic document management systems.
- Ability to work cross-functionally and manage multiple tasks in a deadline-driven environment.