Henry Schein
Rely On Us.
Regulatory Affairs Specialist
Location
United States
Posted
89 days ago
Salary
$61.8K - $85.0K / year
Bachelor Degree2 yrs expEnglish
Job Description
• Responsible for acquiring and maintaining product registrations for domestic and international markets
• Provide direction to the business regarding applicable U.S. and international regulations
• Research and analyze applicable legislation and Federal, State and Local regulations for compliance
• Initiate and maintain medical device product registrations globally
• Support the development of Regulatory strategies and processes
• Work with subsidiary office personnel and distributors for regulatory compliance
Job Requirements
- 2-4 years preferred experience in medical device (U.S. FDA regulated and registered)
- 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
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