Senior R&D Writer - IVD Regulatory Submissions

Werfen is seeking a Sr. R&D Technical Writer to prepare documentation supporting IVDR and FDA regulatory submissions for IVD products.

The role demands a strong understanding of Quality Management Systems and global IVD regulations, and a drive for accuracy and compliance. The successful candidate will author and edit plans, protocols, reports, and product documentation, collaborate with Regulatory Affairs, Quality Control, Clinical Operations and Project Management, and mentor junior staff.