Senior Principal Regulatory Affairs Strategist

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

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.