Senior Regulatory Affairs Specialist

A company is looking for a Senior Regulatory Affairs Specialist to lead global medical device submissions and regulatory strategy.

Key Responsibilities :

Lead and author regulatory submissions for U.S. and international markets

Own regulatory strategy and execution for new product development programs

Serve as the regulatory representative on cross-functional product development teams

Required Qualifications :

Bachelor's degree in Engineering, Science, Regulatory Affairs, or a related technical field

Typically 5-15+ years of experience in medical device regulatory affairs

Demonstrated ownership of FDA submissions and EU technical documentation

Extensive experience with post-market surveillance and regulatory maintenance activities

Working knowledge of international regulatory frameworks and standards