Regulatory Affairs Specialist - Remote

Overview

As a Regulatory Affairs Specialist at Medtronic, you will play a crucial role in shaping policies that enhance healthcare access and equity while ensuring compliance with regulatory standards.

In Short

• Lead submission strategy for regulatory submissions.
• Prepare dossiers for global regulatory submissions.
• Liaise with stakeholders to align on submission plans.
• Respond to queries from FDA/MoH.
• Keep abreast of regulatory procedures and changes.
• Manage databases and trackers related to regulatory activities.
• Participate actively in projects.
• Excellent communication skills are essential.
• 2+ years of regulatory experience in medical devices required.
• Bachelor’s degree in relevant fields is necessary.

Requirements

• Bachelor’s Degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or related field.
• At least 2 years of regulatory experience in medical devices.
• Experience in document interpretation and workflow skills is advantageous.
• Proficiency in Microsoft tools.
• Strong communication skills.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive eligibility through the Medtronic Incentive Plan (MIP).
• Support for career and life stages through a wide range of resources.
• Commitment to employee contributions and success.