Global Regulatory Affairs Manager

Job Summary

A company is looking for a Global Regulatory Affairs Manager.

Key Responsibilities:

• Develop and implement regulatory filing timelines for new and existing products in key markets
• Prepare and submit global market device applications and amendments
• Lead global regulatory assessments for product and manufacturing process changes

Required Qualifications:

• Bachelor's degree in Science, Engineering, Regulatory Affairs, or related fields
• 8-10+ years of experience with Class II and/or III medical devices, including EU MDR/MDD experience
• Extensive experience writing US, EU, and other key market submissions
• Experience with international medical device regulations and standards
• RAC certification is a plus