Global Regulatory Affairs Lead, Medical Devices

Cutera-Inc; Brisbane (CA); On-site; USD 110,000 - 180,000; Full time

Job summary

Cutera-Inc seeks an experienced Regulatory Affairs leader to secure and maintain regulatory approvals for medical devices outside the United States. You will develop strategies, manage submissions, and liaise with distributors and third-party partners to ensure timely registrations and favorable market access.

Responsibilities include maintaining international records, assessing product changes for regulatory impact, and collaborating cross-functionally to meet post-approval obligations and

Qualifications

• 5+ years of regulatory affairs experience in medical devices.
• Experience preparing international registrations and submissions.
• Familiarity with EU MDR and other international requirements.

Responsibilities

• Lead international regulatory strategy for medical devices outside the U.S.
• Prepare and submit regulatory applications for direct and indirect international markets.
• Coordinate with distributors, consultants, and authorized representatives on registrations.
• Review changes affecting international registrations and identify regulatory pathways.
• Maintain up-to-date knowledge of international regulations and guidance documents.
• Collaborate with Quality, R&D, Clinical, Manufacturing, and Commercial teams to support market access.

Skills

Regulatory affairs

Cross-functional collaboration

Project management

Written communication

Strategic thinking

Regulatory submissions

Education

Bachelor’s degree in life sciences

Job description

Cutera-Inc seeks an experienced Regulatory Affairs leader to secure and maintain regulatory approvals for medical devices outside the United States. You will develop strategies, manage submissions, and liaise with distributors and third-party partners to ensure timely registrations and favorable market access.

Responsibilities include maintaining international records, assessing product changes for regulatory impact, and collaborating cross-functionally to meet post-approval obligations and