Regulatory Operations Coordinator

Balt Brasil; Irvine (CA); On-site; 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

Regulatory Operations Coordinator

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.

Job 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.

Qualification 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.

Skills

• 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.).

Pre-requisites / Job Experience

• 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.

Physical Requirements

Hybrid role that is remote and required to be on-site as specified by reporting manager. Extended periods of sitting or speaking. Light lifting. Heavy computer use. Must adhere to the company’s safety practices by performing work safely and in accordance with established standards.

Pay Range

$70,000 - $80,000 USD

Equal Employment Opportunity

Balt Group is an Equal Employment Opportunity employer.