Sr. RA Associate Consultant
Core
Sr. Regulatory Affairs Associate Consultant reviewing, updating, and creating Technical Documents (TDs) for medical device clients in compliance with EU MDR and global regulations.
Role type
Senior Regulatory Affairs Consultant (Contract)
Builds
Technical Documents (TDs) for medical device clients
Domain
Medical Devices / Regulatory Affairs
Required skills
EU MDR knowledge, ISO13485 knowledge, FDA Medical Device regulations knowledge, Technical Document drafting, Quality Control checks, PLM system usage, Adobe PDF management, Cross-functional collaboration
Preferred skills
Life sciences degree, Self-starter attitude, Strong organizational skills
Technologies
PLM, Adobe PDF, Microsoft Office
Responsibilities
Review, update, and create Technical Documents (TDs) in accordance with EU MDR; Identify applicable regulatory requirements and harmonized standards; Perform Quality Control checks on documents; Coordinate with cross-functional teams and local affiliates; Represent Regulatory Affairs on project teams.
Seniority
Senior, hands-on IC