Description

Sr. Regulatory Affairs Specialist needed to perform the following job duties:

• Supporting China TRD Remediation as business unit lead working with and communicating with China RA team and collaborating with local cross function team.
• Supporting Global requests from RA affiliates to support re-registrations.
• Updating Technical Files and appropriate filing.
• Compile 510(K) and Post Market Approval (PMA) submission  supplements and annual reports to maintain commercial approvals in the USA.
• Compile original Technical Files and Design Dossier submissions seeking commercial approval of unapproved assigned product lines in the European Union.
• Provide ongoing support to various cross-functional teams in their requests from regulatory affairs on manufacturing changes and the regulatory submission implications.

Bachelor’s degree required in Chemistry or Regulatory Affairs or Biology or PharmD.