Global Regulatory Strategy Lead - Medical Devices

Cutera-Inc; Raleigh (NC); On-site; USD 140,000 - 195,000; Full time

Job summary

Cutera-Inc in Raleigh, NC seeks a Senior Manager, Regulatory Affairs to lead global regulatory strategy, submissions, and lifecycle management for FDA Class II and EU MDR Class IIb medical devices. You will guide cross-functional teams and ensure regulatory requirements are integrated into development and commercialization plans.

The role requires 8–12 years of Regulatory Affairs experience, strong technical writing, and proven leadership across international markets, including FDA and EU

Qualifications

• Bachelor’s degree in life sciences, engineering, or related scientific/technical discipline.
• 8–12 years of progressive Regulatory Affairs experience in medical devices, including Class II.
• Experience developing and executing regulatory strategies for new products and lifecycle management.
• Strong experience preparing and managing international regulatory approvals, registrations, renewals, and post-approval activities.
• Working knowledge of international medical device regulations, standards, guidance documents, and quality system requirements.
• Ability to interpret complex regulatory requirements and translate into practical strategies.
• Strong technical writing, analytical, and project management skills.

Responsibilities

• Develop and execute global regulatory strategies for products, changes, and lifecycle activities.
• Lead and manage regulatory submissions, registrations, renewals, and approvals internationally.
• Provide regulatory guidance to R&D, QA, Clinical, Operations, Marketing, and other teams.
• Assess changes for regulatory impact and determine submission pathways.
• Monitor global regulations and evaluate impact on products and strategies.
• Support interactions with regulatory authorities and respond to requests for information.
• Drive continuous improvement of regulatory processes and mentor team members.

Skills

Regulatory strategy

Regulatory submissions

Project management

Cross-functional leadership

Technical writing

Regulatory affairs

Communication

Regulatory knowledge

Education

Bachelor’s degree in life sciences, engineering, or related field

Advanced degree in life sciences, engineering, regulatory affairs, or related discipline

Job description

Cutera-Inc in Raleigh, NC seeks a Senior Manager, Regulatory Affairs to lead global regulatory strategy, submissions, and lifecycle management for FDA Class II and EU MDR Class IIb medical devices. You will guide cross-functional teams and ensure regulatory requirements are integrated into development and commercialization plans.

The role requires 8–12 years of Regulatory Affairs experience, strong technical writing, and proven leadership across international markets, including FDA and EU