Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist.

Key Responsibilities

• Represent Regulatory Affairs on core functional teams for post-market changes and regulatory submissions
• Support the review and approval of marketing claims, labeling, and promotional materials
• Collaborate with cross-functional teams to develop compliant advertising and promotional materials

Required Qualifications

• Bachelor's degree and 5-8 years of related experience
• Experience with SaMD regulations and relevant FDA and ISO guidance documents
• Strong writing skills in regulatory documentation and experience interacting with regulators
• Knowledge of global medical device regulations, design controls, and risk management
• Experience in reviewing advertising and promotional materials for medical devices