Trade Compliance Specialist
Henry Schein
Regulatory Affairs Specialist
Henry Schein
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $60,600 - $90,900 per year
Job Level
JuniorMid-Level
About the role
- 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.
Requirements
- 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
- Experience with FDA pre-market submissions preferred
- Experience with ISO 13485 and EU MDR preferred
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory compliancemedical device product registrationsSOP developmentregulatory submissionrisk benefit analysisquality documentation assessmentchange control managementlabel developmentIFU complianceFDA pre-market submissions
Soft skills
analytical skillscommunicationdirection and assistanceorganizational skillsmulti-tasking
Certifications
ISO 13485EU MDR
