Director, Regulatory Affairs, Americas

The Regulatory Affairs Director for the Americas is a senior member of the Global Regulatory Affairs team and offers a rare opportunity to shape regulatory strategy for a growing global business. The role is responsible for leading regulatory affairs across the Americas while also working closely with colleagues in APAC and EMEA on shared priorities, common processes and product compliance topics.

This is a visible, hands-on leadership role for someone who enjoys building, improving and influencing. The organization is still developing its regulatory affairs and quality maturity, so the successful candidate will have the opportunity to create practical processes, build understanding across functions, and make a meaningful impact on how regulatory work is planned, documented and delivered.

The role is well suited to a regulatory leader who wants broad scope and variety. In addition to medical device regulatory affairs, the position includes wider product compliance topics such as packaging requirements, chemical substance restrictions, PFAS, environmental compliance and product stewardship.

The position will help ensure the safe, compliant and timely availability of Hoya Vision Care products across the USA, Canada, LATAM, Brazil, the Caribbean and other relevant markets. It also provides the opportunity to contribute to stronger and more consistent global Regulatory Affairs operations, with direct exposure to senior stakeholders and cross-functional teams.

For the right candidate, this is an opportunity to combine strategic regulatory leadership with practical business impact: supporting important innovation projects, helping bring products to market, and building a more effective regulatory function for the future.

The following is a detailed, but not exhaustive, listing of the tasks you will undertake in the role:

• Develop and implement regulatory strategies for the Americas that align with global business objectives, product development plans and the wider Global Regulatory Affairs strategy.
• Lead and support regulatory submissions and agency interactions, including FDA IDE, pre-submissions, Q-submissions, 510(k), De Novo, breakthrough designation and other applicable approval pathways, as well as registration, listing, renewals and associated activities.
• Maintain submission records and certificates of registration in a regulatory database.
• Act as the direct liaison between the company and regulatory agencies, including FDA and other regional authorities, and represent the company during meetings, inspections and audits.
• Provide practical regulatory guidance to Quality, R&D, Clinical and other teams so that regulatory and quality requirements are built into design control, risk management, testing, clinical evidence, production and post-market activities from the start.
• Act as a regulatory partner on product development and commercial opportunity teams, helping improve protocols, reports, technical documentation and submission content so that FDA interactions, approvals and clearances are supported by clear, complete and compliant evidence.
• Assess regulatory requirements and route-to-market implications for new business opportunities proposed by commercial teams, including products supplied by external partners.
• Lead major regulatory projects, including close collaboration with Clinical, Quality, R&D and external advisers on the current MiYOSMART US clinical and IDE program, challenging gaps early and supporting a clear, evidence-based and compliant route to market.
• Help Quality and R&D understand what evidence, testing, risk management and documentation FDA is likely to expect, and support teams in closing gaps before they become approval, clearance or submission…