Global Regulatory Affairs Senior Manager - Medical Devices

Cutera, Inc.; Raleigh (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Cutera, Inc. is seeking a Senior Manager, Regulatory Affairs to lead global regulatory activities for FDA Class II and EU MDR Class IIb devices. This role shapes regulatory strategy, submissions, and market access across international markets.

You will partner with product development, QA, and operations to ensure compliant design changes, maintain registrations, and support regulatory inspections and inquiries.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 8–12 years of progressive Regulatory Affairs experience in medical devices.
• Experience developing and executing regulatory strategies for product lifecycles.
• Experience managing international regulatory approvals and post-approval activities.
• Knowledge of international medical device regulations and quality system requirements.
• Ability to interpret complex regulations into practical strategies.
• Strong writing, analytical, organizational, and project management skills.
• Ability to lead regulatory activities across multiple projects with timelines.

Responsibilities

• Develop and execute global regulatory strategies for new products and lifecycle management.
• Lead regulatory submissions, registrations, renewals, and approvals across markets.
• Prepare and review regulatory submissions for accuracy and compliance.
• Serve as Regulatory Affairs representative on cross-functional teams.
• Assess regulatory impact of design, manufacturing, labeling changes.
• Provide regulatory guidance to R&D, Quality, Clinical, Operations, Marketing.
• Collaborate with international distributors and regulatory authorities.
• Monitor global regulatory changes and assess impact on products.
• Support inspections, audits, and compliance activities as needed.
• Identify regulatory risks and communicate timelines and impacts to leadership.
• Drive continuous improvement of regulatory processes and tools.

Skills

Regulatory leadership

Regulatory strategy

Regulatory writing

Cross-functional collaboration

Project management

Communication

Mentorship

Education

Bachelor’s degree in life sciences/engineering

Advanced degree (preferred)

Job description

Cutera, Inc. is seeking a Senior Manager, Regulatory Affairs to lead global regulatory activities for FDA Class II and EU MDR Class IIb devices. This role shapes regulatory strategy, submissions, and market access across international markets.

You will partner with product development, QA, and operations to ensure compliant design changes, maintain registrations, and support regulatory inspections and inquiries.