Henry Schein

Rely On Us.

Regulatory Affairs Specialist

ComplianceComplianceFull TimeRemoteTeam 10,001+Since 1932H1B SponsorCompany SiteLinkedIn

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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