Regulatory Specialist


Mansfield, MA

Industry: Technology


Not Specified years

Posted 99 days ago

  by    Cynet EngineeringTeam

This job is no longer available.

We are looking for Regulatory Specialist for our client in Mansfield, MA

Job Title: Regulatory Specialist

Job Location: Mansfield, MA

Job Type: Contract - 12 Months / Contract to Hire / Direct Hire

Job Description:

  • Min 5 year of exp
  • Regulatory Specialist with exeperince in Medical device regulatory filings of
  • Change notification for EU
  • EU-MDR
  • Technical File 
  • Labelling
  • 3-5 years of exepereince in Medical Regulatory
  • Assist in the development, documentation, and implementation of regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements
  • Expereince in Labelling & Packaging related compliances
  • Prepare 510(k), Technical File, CE Mark, and other related regulatory filings.
  • Support IDE and PMA submission preparation as requested
  • Provide regulatory affairssupport to design teams and the document control/change request system.
  • Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
  • Organize regulatory information resources and track and control submissions.
  • Provide status information to regulatory management as required
  • Ensure the timely and accurate filing of regulatory documentation.
  • Develop and maintain product technical files.
  • Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
  • Participate in compliance activities that relate to the department and the company as a whole.
  • Perform other regulatory affairs duties when requested.
  • Technical writing skills. 
  • Experience with data analysis/statistical such as MiniTab or equivalent 


  • Ability to perform all assigned tasks, work independently, and complete work on schedule
  • Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
  • Strong problem solving skills and efficient management of time and resources


  • BE/BS