Regulatory Operations Coordinator

Balt; Irvine (CA); On-site; USD 70,000 - 80,000; Full time

Job summary

Balt Group in Irvine, CA is seeking a Regulatory Operations specialist to maintain documentation, track regulatory activity, and coordinate with internal and external teams for registrations and renewals.

The role requires a science/tech BA/BS and about 1.5 years in a regulated industry, plus proficiency with MS Office and Adobe Acrobat. It is a hybrid position requiring on-site work as directed by the manager, with emphasis on accuracy and collaboration.

Qualifications

• Understand and manage complexities of regulatory documentation.
• Work well in a team and under pressure in timelines.
• Proficient in MS Office and Adobe Acrobat software.
• Experience in a regulated industry is preferred.

Responsibilities

• Operate regulatory operations systems and keep information up to date.
• Coordinate between internal and external resources for regulatory docs.
• Communicate with international partners for feedback on decisions.
• Track regulatory activity and keep records current.
• Create and update KPIs for process health and improvements.
• Summarize regulatory data from internal and external sources.
• Support registration activities like document authentication and submission.
• Ensure device listings and licenses are accurate and current.
• Assist with audits and inspections as needed.
• Perform other duties as assigned.

Skills

Learn new systems

PLM Systems

Quality systems

Education

BA/BS in science or tech

Tools

MS Office

Adobe Acrobat

Job description

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.
• Assist with audits and inspections, as needed.
• Perform 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 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.

Work Environment

Working conditions are normal for an office environment.

Equal Employment Opportunity Statement

Balt Group is an Equal Employment Opportunity employer.

Pay Range

$70,000—$80,000 USD