Director, Regulatory Affairs – Americas
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Leading Americas regulatory strategy for HOYA Vision Care, a global vision-care and optical technology company. Driving medical-device submissions, compliance, and regulatory operations across regional markets.
Responsibilities:
- 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
Similar Jobs
Senior Security Governance, Risk & Compliance Specialist
Senior Security GRC Specialist strengthening Clario’s information security governance, risk, and compliance programs. Coordinating audits, assessments, third-party risk, controls, and security frameworks.
Associate Director, Carrier Compliance
Associate Director leading Medicare Advantage carrier compliance, sales oversight, and remediation for Humana’s healthcare business. Managing compliance professionals and carrier relationships nationwide.
PCI Compliance Specialist, Spanish
PCI compliance specialist supporting customers through VikingCloud’s cybersecurity and compliance platform. Resolving inquiries across phone, chat, email, and ticketing channels.
Compliance Officer
Compliance Officer building AML/KYC operations and EU benchmark licensing readiness for Pyth Network’s institutional data solutions. Managing financial controls, audits, policies, and counterparty risk.
Fraud Compliance Manager
Fraud Compliance Manager overseeing fraud regulations, controls and assurance at digital bank Monzo. Delivering data-led reviews, challenge and remediation across financial crime compliance.
Advisory, Risk & Regulatory, Enterprise Technology Solutions – SAP
SAP risk and regulatory consultant delivering control testing, security, and assurance services. Supporting GRC, ITGC, SOX readiness, and SAP implementation reviews.
Lead Compliance Specialist
Lead compliance specialist developing AML programs, audits, and regulatory reporting for Bybit, a global cryptocurrency exchange. Serving Peru-based compliance operations remotely.
Compliance Officer
Compliance Officer enforcing product compliance, KYC procedures, and ethical service use for Bright Data. Detecting fraud and guiding customers and partners in China or Singapore.
Product Compliance Manager
Product Compliance Manager scaling cloud compliance and assurance across Cisco’s SaaS, on-premises, and hybrid products. Driving automation, regulatory readiness, and executive insights.
Director, Regulatory CMC Strategy
Director leading global Regulatory CMC strategy for Lilly’s small molecule medicines. Driving late-stage submissions, CDMO oversight, and regulatory readiness.
Clinical Regulatory Affairs Specialist II
Clinical Regulatory Affairs Specialist managing regulatory compliance for SCRI’s community-based oncology trials. Maintaining FDA, GCP, IRB, and HIPAA documentation remotely across U.S. research networks.
Data Protection Manager
Data Protection Manager assuring compliant data processing for Atos’s financial-services outsourcing operations. Advising teams and clients on GDPR, breaches, controls, and privacy governance.
Compliance Associate
FIU Compliance Associate investigating financial crime and writing SARs/STRs for Kraken’s global crypto platform. Analyzing transactions, managing compliance volumes, and supporting ad hoc investigations.
Local Contact Person – Pharmacovigilance, Regulatory Affairs
Local pharmacovigilance and regulatory affairs specialist supporting pharmaceutical compliance and patient safety. Managing ADR reporting, regulatory submissions, local requirements, and MAH relationships.
Senior Compliance Officer
Senior Compliance Officer owning global compliance for BHFT, a proprietary algorithmic trading firm. Advising trading teams and governing algorithmic trading across asset classes and jurisdictions.
Regulatory and Start Up Specialist
Regulatory and Start Up Specialist enabling clinical trial approvals and site activation for Precision for Medicine. Managing Spanish submissions, contracts, budgets, and essential documents.
Senior Technical Compliance Analyst
Senior Technical Compliance Analyst strengthening DraftKings’ regulated gaming technology compliance programs. Leading audits, control validation, remediation, and compliance automation across technical teams.
Local Contact Person – Pharmacovigilance and Regulatory Affairs
Local pharmacovigilance and regulatory affairs specialist supporting PrimeVigilance’s pharmaceutical clients. Managing ADR reporting, regulatory submissions, compliance, audits, and local safety requirements.
Regulatory Labeling Manager
Regulatory Labeling Manager supporting Syneos Health’s life sciences clients with health-authority negotiations, safety-data interpretation, and eCTD labeling submissions.
Compliance Manager
Compliance Manager leading UK privacy oversight and DPO responsibilities at Affirm, a buy-now-pay-later company. Driving regulatory governance, monitoring, risk assessments, and second-line control challenge.