Director, Regulatory Affairs, Americas

HOYA Group•Lewisville, TX

About The Position

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.

Requirements

Bachelor's degree in a scientific field, preferably in engineering, life-sciences, or regulatory discipline.
10+ years of Regulatory Affairs experience in the Medical Device industry, preferably in the ophthalmic industry.
5+ years of managerial experience.
Demonstrated ability to define and lead FDA regulatory strategies and submissions for medical devices, including pre-submissions, Q-submissions, 510(k), De Novo and other approval pathways.
Experience supporting novel or clinically supported devices is preferred.
Previous direct interaction with FDA and other regulatory agencies.
Active participation in regulatory or quality associations that provide current regulatory and compliance information.
Experience working with external resources such as legal, quality, regulatory or clinical consultants, both domestic and international.
Experience with broader product compliance topics, such as packaging, chemical substance restrictions, PFAS or environmental compliance, either directly or through external specialists.
Extensive knowledge of ISO 13485 and ISO 14971, and 21 CFR 820 Quality Management System Regulations.
Knowledge of US FDA medical device regulations, Canadian MDR, LATAM requirements such as INVIMA, ANMAT, ISP, COFEPRIS and ANVISA, and other applicable Americas requirements, including relevant Caribbean markets.
Experience with international standards and applicable FDA guidance.
Experience with design control, risk management, design development processes and the technical documentation needed to support regulatory submissions.
Good project management and change management skills, with experience improving regulatory processes and compliance ways of working.
Ability to create order in a developing regulatory environment, including building simple processes, improving documentation, clarifying roles and helping colleagues work in a more consistent and compliant way.
Highly self-motivated and comfortable working independently, with the confidence to shape priorities, drive topics forward and make decisions in areas where regulatory expertise is still being built.
Ability to communicate clearly and work collaboratively with colleagues and stakeholders around the world.
Patient, resilient and able to influence others without direct authority, with a positive approach to helping a complex global organization strengthen its regulatory and quality culture.
Strong ownership, follow-through and judgement, with the ability to create momentum, remove ambiguity and make steady progress even where processes are still evolving.
Excellent organizational skills and attention to detail.
Excellent English verbal and written communication skills.
Flexibility to accommodate working with international colleagues.

Nice To Haves

Experience supporting novel or clinically supported devices is preferred.
Experience with broader product compliance topics, such as packaging, chemical substance restrictions, PFAS or environmental compliance, either directly or through external specialists.

Responsibilities

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 risks.
Engage and manage external contractors, consultants and advisers as needed to support regulatory, clinical, quality or compliance activities.
Manage or support regulatory reporting to FDA and other authorities, including Medical Device Reports, vigilance reports and other post-market reporting obligations in the region.
Create, review and approve compliant labelling, IFUs, product claims, promotional materials and other customer-facing or regulatory documentation, advising on required changes as needed.
Ensure Unique Device Identification labelling and registration in UDI databases is undertaken in compliance with regulatory requirements.
Improve regional and global regulatory operations by developing clearer processes, practical tools, ways of working and governance to support consistent regulatory decision-making across the organization.
Monitor regulatory intelligence and interpret changes in international regulations.
Review design and manufacturing changes for compliance with applicable regulations, FDA guidance and international and domestic standards, including ISO, ANSI and IEC standards.
Provide cross-functional training and guidance to improve organizational understanding of regulatory requirements.
Advise the organization on broader product compliance requirements relevant to the Hoya Vision Care portfolio, including packaging regulations, environmental and chemical substance restrictions, PFAS, and related regional requirements.
Manage routine leadership and administrative responsibilities, including monthly reporting, budget planning and tracking, and oversight of regulatory vendors or consultants.