Sr. Regulatory Operations Coordinator

Balt Group•Irvine, CA

7d•Hybrid

About The Position

The Regulatory Operations Coordinator will support across the Regulatory Affairs Department, with a focus on systems to control & update regulatory data and distribution. The Regulatory Operations Coordinator will coordinate inter- and intra-departmentally to support Regulatory activities and infrastructure.

Requirements

Ability to understand and manage the complexities of regulatory documentation.
Ability to work well in a team environment.
Works well under pressure in a dynamic, timeline-driven environment
Demonstrated MS Office and Adobe Acrobat software skills.
Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
1.5 (one and a half) + years of professional experience working in a regulated industry.

Nice To Haves

Demonstrated ability to quickly learn new systems and processes.
Direct experience with Product Lifecycle Management Systems
Direct experience with quality system processes (e.g., Change Orders, Corrective and Preventive Actions, audits, etc.)

Responsibilities

Operate within Regulatory Operations systems & infrastructure, ensuring information is up to date & accessible.
Coordinate between internal and external resources to generate documentation required to support regulatory registration or renewal activities.
Communicate with international Regulatory, Quality and Sales partners to obtain & act upon feedback regarding potential or confirmed business decisions.
Track regulatory activity, maintain, and update databases, and ensure that records are complete and current.
Create, improve and update metrics on departmental & process performance (KPIs) for reporting on process health & tracking improvements
Obtain, compile & summarize regulatory data from internal and external sources, including data collected from international partners.
Support Regulatory personnel in registration activities such as document authentication (apostille, legalization, notarization), submission compilation, document retrieval/update, etc.
Assure that device listings, import licenses, establishment licenses, and registrations for Balt products are accurate and up to date.
Assists with audits and inspections, as needed.
Performs other duties and responsibilities as assigned.