Regulatory Affairs Coordinator

18 Apr, 2021

Jobs

Regulatory Affairs Coordinator

Pulmodyne
Indianapolis, IN

About the job

As a Regulatory Affairs Specialist, Your Duties Would Include

  • Constructing and maintaining CE Technical files
  • Preparation and support of regulatory submissions
  • Maintaining current regulatory status for current products
  • Maintaining regulatory information required for product import purposes
  • Assist with the preparation of 510K premarket notification applications for submission to FDA
  • Preparation of reports and documents to support international regulatory submissions
  • Preparation of documents and support of activities with Notified Bodies
  • Participate in the assessment of device changes for regulatory implications
  • Identifying new or revised regulatory requirements, guidance documents and product standard
  • Conducting gap analysis when required
  • Coordinating label/DFU requirements and creation of product labels

EMS/Pulmodyne is a fast-growing medical device manufacturer based in Indianapolis, IN. With an existing portfolio of best in class, disposable medical devices, we also maintain strong pipeline via our own in-house R&D team.

Pulmodyne is an open work environment, where contribution and teamwork are valued. We seek to grow through common values and shared ideas. Employees are actively encouraged to challenge the status quo and seek new and better ways of doing business.

Learn more here

Job posted: 2021-04-18