Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities:

• Ensure compliance with applicable regulations in the US
• Liaise and negotiate with FDA and other regulatory authorities for pre-submissions
• Lead the creation and collation of new and updated product market authorization submissions

Required Qualifications:

• Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline
• 2+ years' experience in US Regulatory Affairs roles relating to Medical Devices
• Demonstrated experience of writing, collating, and submitting compliant 510(k) and/or De Novo applications for Class II
• Ability to summarise and explain technical and scientific information for communication internally and with external parties
• Ability to work independently and with colleagues to agreed deadlines