Job Summary

A technology company has an open position for a Telecommuting Regulatory Affairs Professional.

Core Responsibilities Include:

• Developing strategies and approaches for obtaining and maintaining regulatory approvals
• Coordinating activities and timelines with applicable functional groups to complete regulatory submissions
• Representing Regulatory Affairs in quality system audits by external agencies

Applicants must meet the following qualifications:

• Ability to travel up to 15% of the time
• Bachelor’s degree
• At least 3 years of Regulatory Affairs experience in the medical device industry
• Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents
• Experience proactively identifying necessary submission content and assessing the project documentation
• Knowledge of FDA and international regulations related to Class II and Class III implantable medical devices