Virtual Principal Regulatory Affairs Specialist

Job Summary

A medical technology company needs applicants for an opening for a Virtual Principal Regulatory Affairs Specialist.

Individual must be able to fulfill the following responsibilities:

• Provide strategic input and technical guidance on regulatory requirements to develop teams
• Evaluate risk of, and regulatory solutions to, product and clinical safety issues
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies

Qualifications Include:

• Travel 20%
• Bachelor’s degree (BS or BA) in Engineering, Science, Regulatory or equivalent focus
• 9 years professional experience
• 5 years direct regulatory affairs experience within the medical device industry
• Expert knowledge of medical device regulations with an emphasis on FDA and leading regulatory strategy
• Understanding of the FDA device listing and establishment registration process