Senior Principal Regulatory Affairs Specialist

Balt; Irvine (CA); On-site; USD 170,000 - 200,000; Full time

Job summary

Balt is a rapidly growing pioneer in medical devices with a global footprint and a mission to help physicians save lives. Balt seeks a Senior Principal Regulatory Affairs Specialist to lead complex regulatory approvals and ensure compliance across US and international markets.

The role requires deep regulatory expertise, program leadership, and collaboration with cross-functional teams to drive project success and maintain approvals while advancing innovative therapies.

Qualifications

• Minimum BA/BS in a scientific or technical field.
• 9+ years of professional regulatory experience.
• Experience preparing US and EU submissions.

Responsibilities

• Develop global regulatory strategies for complex, high-risk medical devices including contingency plans.
• Represent Regulatory Affairs on project teams and partners with cross-functional teams to ensure alignment of regulatory strategies and organizational objectives.
• Writes, reviews and files regulatory submissions and documentation for the US and internationally.
• Support product maintenance for currently marketed products, as necessary.
• Reviews device labeling for compliance with the applicable US and international regulations.
• Reviews product and manufacturing changes for compliance with applicable regulations.
• Reviews advertising and promotion to ensure compliance with product claims
• Documents, consolidates, and maintains verbal and written communication with regulatory agencies.
• Identify and evaluate regulatory processes and systems for improvements ensuring compliance
• Assists with audits and inspections, as needed
• Performs other duties and responsibilities as assigned.

Skills

HDE/IDE/PMAs experience

Project management

Team collaboration

Ability to work under pressure

MS Office

Adobe Acrobat

Education

BA/BS in scientific or technical discipline

Tools

MS Office

Adobe Acrobat

Job description

About Balt
Our purpose is to improve the lives of 150,000 patients in 2026.

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. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.
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.
• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
• 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!
Description
About this opportunity – Senior Principal Regulatory Affairs Specialist
The Sr. Principal Regulatory Affairs Specialist is a seasoned expert, responsible for completing and maintaining regulatory approvals/clearances for new and modified medical devices, license renewals, and annual registrations. Serves as a Regulatory representative on specific multi-discipline teams, responsible for organizing and leading meetings and acts independently to identify and resolve problems that may be complex in nature. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of projects. Interacts directly with regulatory bodies.
Job Responsibilities

• Develop and implement global regulatory strategies for complex, high-risk medical devices including contingency plans.
• Represent Regulatory Affairs on project teams and partners with cross-functional teams to ensure alignment of regulatory strategies and organizational objectives.
• Writes, reviews and files regulatory submissions and documentation for the US and internationally.
• Support product maintenance for currently marketed products, as necessary.
• Reviews device labeling for compliance with the applicable US and international regulations.
• Reviews product and manufacturing changes for compliance with applicable regulations.
• Reviews advertising and promotion to ensure compliance with product claims
• Documents, consolidates, and maintains verbal and written communication with regulatory agencies.
• Identify and evaluate regulatory processes and systems for improvements ensuring compliance
• Assists with audits and inspections, as needed
• Performs other duties and responsibilities as assigned.
  

Qualification Requirements
Skills:

• Experience in Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications
• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
• 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
  

Pre-Requisites/Job Experience:

• Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
• Nine (9) + years of professional regulatory experience.
• Documented experience in preparation of US and EU submissions
• Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
  

Physical Requirements:

• Must be able to remain in a stationary position 50%
• Constantly operate a computer and other office equipment, such as copy machine, printer, etc.
  

Work Environment
Working conditions are normal for an office environment.

The above information on this description have been designed to indicate the general nature of work performed by employees within this position. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
Balt Group is an Equal Employment Opportunity employer.
More information please go to www.baltgroup.com
Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.
Pay Range

$170,000—$200,000 USD