Regulatory Affairs Specialist II - LanceSoft Inc

Chaska, MN 55318

Pay: $31.92/hr
Hours: Day Shift/ Monday to Friday

Responsibilities:

Investigate regulatory history of similar products to assess approval implications.
Meet and follow policies and procedures to complete milestones.
Communicate with internal technical (engineers/scientists) and regulatory personnel.
Interpret and evaluate data.
Write and edit technical documents.
Prepare and submit IVDR documentation.
Prepare and submit Global registration documentation.
Electronic submission process, types and requirements (CLARA).
Monitor applications under regulatory review.
Maintain regulatory files.
Import/export requirements.
Update and maintain paper/ electronic document archival systems.
Determine product regulatory path or class.
Evaluate design changes for regulatory filing strategies.
Assess regulatory impact and risk.
Develops plan for timely renewal registrations to ensure continued product supply.
Communicate closely with the Headquarters on the needs and problems of registration documentation and registration test.

Source : LanceSoft Inc