Global Regulatory Affairs Director – Medical Devices

Cutera; Raleigh (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Cutera, based in Raleigh, NC, seeks a Senior Manager, Regulatory Affairs to lead global regulatory activities for FDA Class II and EU MDR Class IIb devices. You will shape regulatory strategies, guide lifecycle management, and manage complex submissions across international markets.

Ideal candidate has 8–12 years in medical device regulatory affairs, strong writing and cross-functional collaboration skills, and a track record of leading global regulatory programs with multi-market experience.

Qualifications

• Bachelor’s degree in life sciences, engineering, or a related scientific or technical discipline.
• 8–12 years of progressive Regulatory Affairs experience within the medical device industry, including experience supporting Class II or comparable regulated medical devices.
• Demonstrated experience developing and executing regulatory strategies for new product development, product changes, and lifecycle management.
• Strong experience preparing and managing international regulatory approvals, registrations, renewals, amendments, and related post-approval activities.
• Working knowledge of international medical device regulations, standards, guidance documents, and quality system requirements.
• Demonstrated ability to interpret complex regulatory requirements and translate them into practical business and product development strategies.
• Strong communication and interpersonal skills with the ability to influence and collaborate across functions.

Responsibilities

• Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities in alignment with business and product development priorities.
• Lead and manage regulatory submissions, registrations, renewals, and approvals across international markets.
• Prepare, review, and approve regulatory submissions and supporting documentation to ensure accuracy, completeness, scientific validity, and compliance with applicable requirements.
• Serve as the Regulatory Affairs representative on product development and cross-functional project teams, providing strategic guidance throughout the product lifecycle.
• Assess product, design, manufacturing, labeling, and other changes for regulatory impact and determine appropriate regulatory pathways and submission requirements.
• Provide regulatory guidance to R&D, Quality, Clinical, Operations, Marketing, and other cross-functional stakeholders.
• Partner with international distributors, consultants, and regulatory representatives to support registrations and maintain market access in direct and indirect markets.
• Monitor changes to global regulations, guidance documents, and consensus standards, and evaluate potential impact to company products and regulatory strategies.
• Support interactions with regulatory authorities and other external regulatory bodies, including responses to questions and requests for additional information.
• Identify regulatory risks, develop mitigation strategies, and communicate regulatory requirements, timelines, and potential business impacts to key stakeholders and leadership.
• Drive continuous improvement of regulatory processes, procedures, tools, and best practices to support an effective and scalable regulatory function.
• Provide regulatory guidance, mentorship, and subject matter expertise to Regulatory Affairs team members and cross-functional partners.
• Support regulatory inspections, audits, and compliance activities as needed.
• Other duties as needed or required.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Technical writing

Regulatory guidance

Education

Bachelor's degree in life sciences/engineering

Advanced degree in life sciences or engineering

Job description

Cutera, based in Raleigh, NC, seeks a Senior Manager, Regulatory Affairs to lead global regulatory activities for FDA Class II and EU MDR Class IIb devices. You will shape regulatory strategies, guide lifecycle management, and manage complex submissions across international markets.

Ideal candidate has 8–12 years in medical device regulatory affairs, strong writing and cross-functional collaboration skills, and a track record of leading global regulatory programs with multi-market experience.