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.