Senior Principal Regulatory Affairs Specialist

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

Job summary

Balt USA in Irvine, CA is seeking a Senior Principal Regulatory Affairs Specialist to lead regulatory approvals for high-risk medical devices, oversee submissions in the US and internationally, and guide cross-functional teams.

You will develop global regulatory strategies, interact with regulatory agencies, and mentor teams while maintaining compliance and timelines.

Requires nine+ years of regulatory experience, proven PMA/IDE/HDE experience, and strong writing and communication skills.

Qualifications

• Experience with HDE/IDE/PMAs and other regulatory pathways.
• Strong project management, writing, coordination, and execution of regulatory items.

Responsibilities

• Develop and implement global regulatory strategies for complex, high-risk medical devices.
• Represent Regulatory Affairs on project teams and align regulatory strategies with objectives.
• Prepare, review, and file regulatory submissions and documentation for US and international markets.
• Support maintenance of currently marketed products as needed.
• Review labeling for compliance with US and international regulations.
• Assess manufacturing changes for regulatory impact and compliance.
• Review advertising to ensure claims are compliant.
• Maintain communications with regulatory agencies and document interactions.
• Identify regulatory process improvements to ensure compliance.
• Assist with audits and inspections as needed.
• Perform other duties as assigned.

Skills

Regulatory strategy

Project management

Regulatory submissions

Cross-functional collaboration

Education

BA/BS in science or engineering

Tools

MS Office

Adobe Acrobat

Job description

About Balt

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

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

• 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

Pay Range: $170,000 USD - $200,000 USD