Regulatory Operations Coordinator — Hybrid

Balt Brasil; Irvine (CA); Hybrid; USD 70,000 - 80,000; Full time

Job summary

Balt Group is seeking a Regulatory Operations Coordinator to support the Regulatory Affairs Department by managing regulatory data systems and distribution. The role coordinates inter- and intra-departmentally to support regulatory activities and infrastructure.

You will work with international partners, track activity, maintain databases, and contribute to KPI reporting for process health and improvements. Hybrid role with on-site requirements as determined by management.

Qualifications

• Understanding regulatory documentation complexities.
• Ability to work well in a team.
• Works well under pressure in a dynamic, timeline-driven environment.
• Demonstrated MS Office and Adobe Acrobat software skills.

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.

Skills

Learn new systems

Product Lifecycle Management

Quality system processes

Education

BA/BS in scientific or technical field

Tools

MS Office

Adobe Acrobat

Job description

Balt Group is seeking a Regulatory Operations Coordinator to support the Regulatory Affairs Department by managing regulatory data systems and distribution. The role coordinates inter- and intra-departmentally to support regulatory activities and infrastructure.

You will work with international partners, track activity, maintain databases, and contribute to KPI reporting for process health and improvements. Hybrid role with on-site requirements as determined by management.