Global Regulatory Strategy Lead — Medical Devices

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

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.