Senior Specialist Medical Device

Overview

Senior Specialist Medical Device role focused on managing global regulatory product documentation and compliance across product design, development, and lifecycle approvals.

What you'll do

• Manage global regulatory product documentation including technical files, registration dossiers, IFUs, and labeling.
• Ensure compliance with regulatory standards and testing requirements during product design and development.
• Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities.
• Manage registrations, renewals, and submissions to support global regulatory product availability.
• Lead regulatory product strategies for the medical device products.
• Handle regulatory documentation for product and process changes.

What you'll need

• Experience working with regulatory documentation such as technical files, registration dossiers, IFUs, and labeling.
• Ability to ensure compliance with regulatory standards and testing requirements.
• Experience coordinating approvals and change notifications with Notified Bodies and Authorities.
• Experience managing registrations, renewals, and submissions for regulatory availability.
• Experience leading regulatory product strategies.
• Experience managing regulatory documentation for product and process changes.