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Regulatory Affairs Specialist
Ref No.: 18-27569
Location: Plymouth, Minnesota
Start Date / End Date: 06/04/2018 to 06/07/2019
Company: Artech Information Systems
Job Title: Regulatory Affairs Specialist
Location: Plymouth, MN
Job ID: 18-27569
Duration: 12 months
The Regulatory Affairs Specialist will assist MITG- Lung Health Regulatory Affairs in the preparation and implementation of European Medical Device Regulation (EU MDR) requirements.
  • Assist in analysis of tech file and STED (summary of technical documentation) with goal of harmonization of a submission template
  • Develop a process to implement electronic tech file submission within Agile
  • Data entry and maintenance of remediation efforts within MP3; ensure the ramp-up in MP3 data is maintained correctly; maintenance of data for projects in-process, generating reports monthly and as needed
  • Participate in compliance activities that relate MITG
  • Compile information to generate bi-weekly, monthly, quarterly and yearly dashboards and/ or budget reports as needed
  • Perform other regulatory affairs duties when requested; while the initial focus will be on EU MDR for MITG, duties may include other programs and processes
  • Responsible for ensuring MITG commitments are met; and communicating program status as needed
  • Other duties as assigned with or without accommodation.
Education required:
Bachelor’s Degree in Biomedical Science, Engineering, Quality or related technical field; RAC preferred
Two to four years in the medical device industry; Quality and / or Regulatory experience needed.
Preferred Skills/ Qualifications:
  • Experience /exposure with European Union submission
  • Good understanding to regulations and policies
  • Registration experience on CE mark, 510K or registration
  • Proficiency in MS Word, Excel, PowerPoint, etc.
  • Working knowledge of MS Project, internal systems including SharePoint, BOX, Agile
  • High learning aptitude and adaptability with software /internal systems
  • Excellent written and verbal communication skills
  • Highly organized, efficient and self-motivated
  • Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure
  • Team player who seeks to help and learn from colleagues
  • Proactively seeks to develop and become well-versed within in the regulatory landscape
Rajiv Maruthi