Regulatory Affairs Specialist II - LanceSoft Inc
Chaska, MN 55318
About the Job
Pay: $31.92/hr
Hours: Day Shift/ Monday to Friday
Responsibilities:
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