Regulatory Affairs Specialist: Global Submissions

Regulatory Jobs; Plymouth (MN); On-site; USD 73,000 - 108,000; Full time

Benefits offered by this job

Medical benefits

401(k) with match

Paid time off

Job summary

Integer, a global provider of medical-device and battery technology, seeks a Regulatory Affairs specialist in the United States. You will support regulatory teams, prepare national and international submissions, and maintain regulatory files in a structured quality system.

You will collaborate with cross-functional teams to ensure compliance with FDA regulations and global regulatory requirements while maintaining documentation and databases.

Qualifications

• The role requires familiarity with regulatory processes and documentation practices.
• Experience working with regulatory submissions and quality systems is preferred.
• Strong attention to detail and ability to manage multiple regulatory tasks.

Responsibilities

• Provide team support to Regulatory Affairs managers and department management.
• Develop strategies and prepare submissions for national and international product registrations.
• Prepare and maintain regulatory files, regulatory reports, and databases.
• Coordinate review responses to regulatory inquiries and notifications.

Skills

Regulatory affairs

FDA regulations

Quality systems

Documentation

Education

Bachelor's degree

Job description

Integer, a global provider of medical-device and battery technology, seeks a Regulatory Affairs specialist in the United States. You will support regulatory teams, prepare national and international submissions, and maintain regulatory files in a structured quality system.

You will collaborate with cross-functional teams to ensure compliance with FDA regulations and global regulatory requirements while maintaining documentation and databases.