Henry Schein · 1 month ago
US Regulatory Affairs Specialist
United States
Full-time
Remote
Entry, Mid Level
$62K/yr - $85K/yr
2+ years expHenry Schein is a leading provider of health care products and services. The US Regulatory Affairs Specialist is responsible for acquiring and maintaining product registrations for domestic and international markets while ensuring compliance with applicable regulations.
DentalHealth CareMedical Device
Responsibilities
Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements
Initiate and maintain medical device product registrations globally, focusing on international markets
Support the development of Regulatory strategies and processes
Works with subsidiary office personnel and distributors to provide direction and assistance in all matters of product legal/regulatory compliance, registrations and availability in domestic/international markets
Ensure only products legally registered are sold into international markets in accordance with U.S. export regulations
Assist in SOP development and review
Provide regulatory input to product lifecycle planning
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Determine and communicate submission and approval requirements
Participate in risk benefit analysis for regulatory compliance
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare, review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies
Monitor applications under regulatory review
Provide support during inspections and formulating the appropriate response and corrective actions
Assist compliance with product post marketing approval requirements
Review regulatory aspects of contracts
Assist with label and Instructions for Use (IFU) development and review for compliance before release
Ability to manage multiple establishment and product registration activities
Submit and review change controls to determine the level of change and consequent submission requirements
Provide regulatory input for product recalls and recall communications
Other duties as assigned
Qualification
Required
2-4 years preferred experience in medical device (U.S. FDA regulated and registered) Manufacturer or Specification Developer in the U.S. and/or Foreign regulatory submissions
Good understanding of industry practices
Proficient with tools, systems, and procedures
Basic planning/organizational skills and techniques
Good decision making, analysis and problem solving skills with ability to multi-task
Good verbal and written communication skills
Good presentation and public speaking skills
Good interpersonal skills
Basic conflict resolution skills
Developing professional credibility
Typically 2 to 4 or more years of increasing responsibility in terms of any applicable professional experience
Preferred
Experience with FDA pre-market submissions preferred
Experience with ISO 13485 and EU MDR preferred
Typically a Bachelor's Degree or global equivalent in related discipline
Benefits
Medical, Dental and Vision Coverage
401K Plan with Company Match
PTO
Paid Parental Leave
Income Protection
Work Life Assistance Program
Flexible Spending Accounts
Educational Benefits
Worldwide Scholarship Program
Volunteer Opportunities
Company
Henry Schein
Henry Schein is a provider of health care products and services to office-based dental, medical and animal health.
10001+ employees
H1B Sponsorship
Henry Schein has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (5)
2023 (6)
2022 (6)
2021 (1)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$1BKey Investors
Kohlberg Kravis RobertsSMILE Health
2025-01-29Post Ipo Equity· $250M
2023-08-08Non Equity Assistance
2023-07-11Post Ipo Debt· $750M
Leadership Team
James A. Harding
SVP & CTO
Michael Ettinger
Executive Vice President, Chief Operating Officer
Recent News
Medical Product Outsourcing
2026-01-16
2026-01-16
Digital Commerce 360
2026-01-16
Company data provided by crunchbase