Regulatory Specialist

  •  

Mansfield, MA

Industry: Technology

  •  

Not Specified years

Posted 45 days ago

  by    Cynet EngineeringTeam

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 

Skills:

  • 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

Education:

  • BE/BS