Our client is looking for a Regulatory Affairs Specialist II to join their team for 6 months. Their team is a handful of members supporting Americas, EU, and the Middle East for their RF technologies and Lasers. They have a lot of work in maintaining documentation and are currently integrating with their new team out of Korea. There is a large focus on integrating their technologies into the organization and firming up registrations in the markets. This candidate will be working on change documentation, remediating CE marking technical files as well as supporting some registration work. They will either be supporting the registration work directly with agents or indirectly by pulling together files and reviewing for compliance. This candidate may also be required to complete submission writing for the FDA or Health Canada.

Requirements:

• Experience doing promotional material review
• Remediation experience
• Experience writing procedures

Preferred Experience:

• Previous experience working with RF technologies or Lasers
• Experience using SAP as a PLM system for ERP