Hybrid Regulatory Operations Specialist - Data-Driven

Balt; Irvine (CA); Hybrid; 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

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.