Regulatory Operations Specialist - Remote

Overview

The Regulatory Operations Specialist at Medtronic will focus on enhancing regulatory systems and processes while ensuring compliance with FDA regulations related to medical devices.

In Short

• Lead regulatory operations related to FDA registrations and listings.
• Collaborate with internal and external stakeholders.
• Manage the Owner/Operator account and provide guidance.
• Ensure data integrity within regulatory systems.
• Support audits and inspections.
• Conduct training sessions for various stakeholders.
• Participate in initiatives to improve regulatory processes.
• Communicate effectively with internal teams.
• Maintain documentation for compliance purposes.
• Contribute to the Unique Device Identification (UDI) system.

Requirements

• Bachelor's degree with at least 2 years of relevant experience.
• Strong understanding of FDA regulations.
• Experience with DRLM in FURLS is a plus.
• Advanced proficiency in Microsoft Office and other tools.
• Excellent organizational and project management skills.
• Strong communication skills, both written and oral.
• Ability to work under pressure in a dynamic environment.
• Understanding of UDI requirements.
• Flexibility with changing priorities.
• Professional presentation and team player attitude.

Benefits

• Competitive salary and flexible benefits package.
• Health, dental, and vision insurance.
• Tuition assistance and reimbursement.
• Incentive plans and 401(k) with employer match.
• Paid time off and holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Long-term disability leave.
• Dependent daycare spending account.
• Global well-being program.