Balt
Sr. Regulatory Operations Coordinator
Irvine, Orange County · Senior
Sponsorship not specified$70k-$80kDetected 5 days ago
Product ManagementFDA RegulatoryMedical DevicesCommunicationMicrosoft OfficeRegulatory Affairs
About the role
- About Balt Our purpose is to improve the lives of 150,000 patients in 2026.
- Our story Balt is a rapidly growing pioneer in an exceptional field.
- Our products are being used by physicians across the world, and we have 13 offices in 11 countries - and counting.
Responsibilities
- 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.
- 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.
- Performs other duties and responsibilities as assigned.
Requirements
- Ability to work well in a team environment.
- Coordinate between internal and external resources to generate documentation required to support regulatory registration or renewal activities.
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.
Compensation
- $70,000 - $80,000 USD
Benefits
- We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
- Create, improve and update metrics on departmental & process performance (KPIs) for reporting on process health & tracking improvements
Company info
- Balt is a rapidly growing pioneer in an exceptional field.
- For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.
- We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke.
- As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.
- We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.
- Why Join Balt?
- Join a passionate team, dedicated to making a difference.
- Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
- Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
- No matter the country, we take care of you.
- Would you like to be part of our story?
- Don't hesitate, come and join us!
This listing is sourced directly from Balt's careers page and normalized into a canonical job model.