Global Regulatory Submissions Specialist

Integer Holdings; Plymouth (MN); In loco; USD 73.000 - 108.000; Tempo pieno

Descrizione del lavoro

Integer is a global organization delivering innovative technologies and manufacturing for Medical Device OEMs and niche batteries. The Regulatory Affairs role focuses on capturing, archiving, and publishing regulatory documents, preparing national and international submissions, and maintaining regulatory files and databases.

You will support audits and ensure QMS adherence, aligning with FDA and EU MDR requirements.

Competenze

• Bachelor's degree preferred; 1 year regulatory experience may be considered.
• Knowledge of EU MDR and US FDA regulations.
• Able to work independently and with cross-functional teams.
• Strong MS Office skills (PowerPoint, Visio, Project).
• Excellent written and oral communication skills.

Mansioni

• Capture, archive, and publish regulatory documents.
• Prepare submissions for national and international registrations.
• Maintain regulatory files, regulatory reports, and databases.
• Coordinate review of customer information requests and responses.
• Support internal quality system audits and Notified Body audits.
• Ensure compliance with QMS and safety requirements.

Conoscenze

Regulatory knowledge

Document control

Quality systems

Formazione

Bachelor's degree

Strumenti

FDA FURLS

GUDID

EUDAMED

Descrizione del lavoro

Integer is a global organization delivering innovative technologies and manufacturing for Medical Device OEMs and niche batteries. The Regulatory Affairs role focuses on capturing, archiving, and publishing regulatory documents, preparing national and international submissions, and maintaining regulatory files and databases.

You will support audits and ensure QMS adherence, aligning with FDA and EU MDR requirements.