Regulatory Affairs Director

Role Overview:

The Director, Regulatory Affairs leads a team responsible for developing and executing regulatory strategies for new and revised products in global markets. This role provides strategic leadership within the R&D Senior Leadership Team, ensuring regulatory requirements are embedded in design, development, and lifecycle management activities.

The position partners closely with R&D Quality Assurance and other functions to align regulatory compliance with innovation and commercialization goals.

Key Responsibilities:

• Develop and execute regulatory strategies for timely market introduction of new or revised products.
• Integrate regulatory requirements into product design and development.
• Provide strategic regulatory guidance to R&D leadership and cross-functional teams.
• Lead, coach, and develop a high-performing NPI Regulatory Affairs team.
• Ensure regulatory documentation meets internal and external standards using eQMS and RIM systems.
• Engage with external regulatory bodies to influence outcomes and maintain compliance.
• Drive continuous improvement in regulatory processes, systems, and ways of working.
• Manage team resources, budgets, and capability planning.

Travel:

Approximately 20% globally.

Qualifications & Skills:

• Proven leadership experience and ability to influence across teams.
• In-depth knowledge of EU, US FDA, and international medical device regulations.
• Experience with Quality Management Systems (ISO13485, MDSAP).
• Strong analytical, communication, and project management skills.
• Ability to navigate complex, technical material and work under deadlines.
• Fluent in English; culturally adaptable for global operations.
• Proficiency in Microsoft Office; advanced Excel/PowerPoint skills preferred.

Experience & Education:

• Minimum 15 years in medical device regulatory affairs and quality assurance.
• Minimum 8 years in leadership across multiple countries or cultures.
• Bachelor’s degree required; advanced degree preferred.
• ISO13485 auditor and/or QA Manager experience is a plus.
• Optical/contact lens industry experience is advantageous.

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