Global Medical Device Regulatory Lead

Cutera; Brisbane (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

Cutera, located in BRISBANE HQ - BRISBANE, CA, is seeking an International Regulatory Leader to secure and maintain regulatory approvals for medical devices outside the United States. You will develop strategies, manage submissions, and coordinate with distributors and consultants to navigate global markets.

You will collaborate with Quality, R&D, Manufacturing, and Commercial Sales to ensure timely registrations and responsiveness to market changes.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Minimum of 5 years of regulatory affairs experience in the medical device industry.
• Experience with international registrations, renewals, amendments, and regulatory submissions.
• Experience with international distributors/regulatory consultants and/or authorized representatives.
• Knowledge of international medical device regulations and quality system requirements.

Responsibilities

• Manage and track international regulatory approvals, registrations, renewals, amendments, and related post-approval activities.
• Prepare, coordinate, and submit regulatory applications for direct international markets.
• Support distributors, authorized representatives, and third-party regulatory consultants with submissions and registrations in non-direct international markets.
• Serve as the primary Regulatory Affairs contact for routine international distributor, consultant, and sales communications.
• Author and review international regulatory submissions and supporting documentation, ensuring content is accurate, organized, scientifically sound, and completed within established timelines.
• Assess product, labeling, manufacturing, supplier, and process changes for impact on international registrations and determine applicable notification, approval, or documentation requirements.
• Maintain current knowledge of international regulations, guidance documents, standards, and market-specific requirements; communicate relevant changes and potential impacts to internal stakeholders.
• Collaborate with Quality, R&D, Clinical, Manufacturing, Commercial Sales, and other cross-functional teams to obtain documentation and support international regulatory and market access objectives.
• Maintain international registration records, trackers, and supporting documentation in accordance with internal procedures.

Skills

Regulatory expertise

Regulatory strategy

Project management

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Cutera, located in BRISBANE HQ - BRISBANE, CA, is seeking an International Regulatory Leader to secure and maintain regulatory approvals for medical devices outside the United States. You will develop strategies, manage submissions, and coordinate with distributors and consultants to navigate global markets.

You will collaborate with Quality, R&D, Manufacturing, and Commercial Sales to ensure timely registrations and responsiveness to market changes.