Global Regulatory Lead — Medical Devices

Cutera, Inc.; Brisbane (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Cutera, Inc. is seeking an International Regulatory Leader to secure and maintain approvals for medical devices outside the United States.

You will shape international regulatory strategies and manage submissions, working with distributors and third‑party partners to ensure timely market access. You will collaborate with Quality, R&D, Clinical, Manufacturing, and Commercial teams to assess changes, maintain records, and stay current with global requirements.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Minimum of 5 years of regulatory affairs experience in medical devices.
• Experience preparing and supporting international registrations, renewals, amendments, and submissions.
• Experience with international distributors, regulatory consultants, and authorized representatives.
• Working knowledge of international medical device regulations, standards, and QMS requirements.
• Strong regulatory, analytical, and written communication skills.
• Ability to manage multiple activities and meet deadlines.
• Strong cross-functional collaboration and project management skills.

Responsibilities

• Manage and track international regulatory approvals, registrations, renewals, amendments, and 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 accuracy and timeliness.
• Assess product, labeling, manufacturing, supplier, and process changes for impact on international registrations.
• Maintain knowledge of international regulations and communicate changes to stakeholders.
• Collaborate with Quality, R&D, Clinical, Manufacturing, and Commercial teams to support regulatory objectives.
• Maintain international registration records and trackers.
• Other duties as needed.

Skills

Regulatory affairs

Medical devices

International registrations

Submission management

Project management

Cross-functional collaboration

Written communication

Education

Bachelor’s degree in life sciences

Job description

Cutera, Inc. is seeking an International Regulatory Leader to secure and maintain approvals for medical devices outside the United States.

You will shape international regulatory strategies and manage submissions, working with distributors and third‑party partners to ensure timely market access. You will collaborate with Quality, R&D, Clinical, Manufacturing, and Commercial teams to assess changes, maintain records, and stay current with global requirements.