Regulatory Affairs

  • location: East Mansfield, MA
  • type: Temp to Perm
  • salary: $38 - $43 per hour
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job description

Regulatory Affairs

Contract position: Medical Device company needs a Regulatory Affairs Product Specialist in Mansfield MA to support of international product registrations. This is a 12 month contract, likely extension up to 30 months. Great contractor benefits

Responsibilities for the Regulatory Affairs
  • Collaborate with regional regulatory teams to obtain adequate and accurate registration documents upon fully understanding the local regulations
  • Support worldwide product registrations
  • Maintain country specific site registration requirements
  • Maintain current regulatory databases to ensure accurate regulatory data
  • Act as liaison between regional regulatory personnel and cross functions to address questions and issues that arise during the registration reviews and/or local product testing
Requirements for the Regulatory Affairs

  • BS in Engineering
  • 1+ years medical device or pharma experience supporting product registrations
  • Entry level knowledge of U.S. and/or European/International regulations and standards
  • 1-2 years' experience Quality Management system
Benefits

  • Insurance, 401K,PTO
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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