Director, Regulatory Affairs – Americas

Job not on LinkedIn

🔥 16 hours ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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HOYA Surgical Optics

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1980

🏭 Manufacturing

🏥 Healthcare

Manufacturing • Medical Devices • Healthcare

HOYA Surgical Optics is a company dedicated to refining and perfecting technologies and solutions for the healthcare industry, focusing on intraocular lenses (IOLs). They offer a range of preloaded IOLs such as Vivinex, Nanex, and ezSert. These products are designed to restore sight, enabling patients to experience a more vibrant world. HOYA Surgical Optics provides personalized services and specialized support to healthcare professionals, ensuring smart and seamless integration of their products into medical practices.

📋 Description

• Develop and implement regulatory strategies for the Americas aligned with global business objectives and product development plans • Lead and support regulatory submissions and agency interactions, including FDA IDE, pre-submissions, Q-submissions, 510(k), De Novo, breakthrough designation and other approval pathways • Maintain submission records and certificates of registration in a regulatory database • Liaise directly with FDA and other regional regulatory authorities and represent the company during meetings, inspections and audits • Provide regulatory guidance to Quality, R&D, Clinical and other teams across design control, risk management, testing, clinical evidence, production and post-market activities • Partner with product development and commercial opportunity teams on protocols, reports, technical documentation and submission content • Assess regulatory requirements and route-to-market implications for new business opportunities and externally supplied products • Lead major regulatory projects, including the MiYOSMART US clinical and IDE program • Support teams in closing evidence, testing, risk management and documentation gaps • Engage and manage external contractors, consultants and advisers • Manage or support FDA and other authority reporting, including Medical Device Reports, vigilance reports and post-market reporting • Create, review and approve compliant labelling, IFUs, product claims, promotional materials and regulatory documentation • Ensure Unique Device Identification labelling and registration in UDI databases • Improve regional and global regulatory operations through clearer processes, tools, ways of working and governance • Monitor regulatory intelligence and interpret changes in international regulations • Review design and manufacturing changes for compliance with regulations, FDA guidance and ISO, ANSI and IEC standards • Provide cross-functional training and guidance on regulatory requirements • Advise on packaging regulations, environmental and chemical substance restrictions, PFAS and related product compliance requirements • Manage monthly reporting, budget planning and tracking, and regulatory vendor or consultant oversight

🎯 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 • 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 • 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 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 • Extensive knowledge of ISO 13485, ISO 14971 and 21 CFR 820 Quality Management System Regulations • Knowledge of US FDA medical device regulations, Canadian MDR, LATAM requirements including INVIMA, ANMAT, ISP, COFEPRIS and ANVISA, and other applicable Americas requirements • Experience with international standards and applicable FDA guidance • Experience with design control, risk management, design development processes and technical documentation for regulatory submissions • Good project management and change management skills • Excellent organizational skills and attention to detail • Excellent English verbal and written communication skills • Flexibility to accommodate working with international colleagues • Willingness to travel occasionally, domestically and internationally, expected to be less than 10% of the time

🏖️ Benefits

• Remote work arrangement • Occasional domestic and international travel expected to be less than 10% of the time