Senior Regulatory Affairs Specialist

Our client, an innovative medical device company, is seeking a Senior Regulatory Affairs Specialist to support regulatory strategy and submissions for complex Class III products.

This is a hands-on role for a regulatory professional who can both lead and execute. The successful candidate will drive key submission activities while working closely with Clinical, Quality, R&D, and Manufacturing teams in a fast-paced, growth-oriented environment.

Responsibilities

• Develop and execute regulatory strategies for Class III medical devices.
• Lead and author FDA and global regulatory submissions, including:
• PMA applications and supplements
• IDE submissions and amendments
• Global registrations and post-approval submissions
• Serve as the regulatory lead on cross-functional product teams.
• Assess regulatory impact of product changes and development activities.
• Provide regulatory guidance related to design controls, risk management, clinical activities, and product commercialization.
• Support interactions with FDA and other regulatory authorities.

Qualifications Required

• Bachelor's degree in a scientific or engineering discipline.
• 5+ years of medical device Regulatory Affairs experience.
• Strong experience with PMA submissions and Class III devices.
• Proven ability to lead submissions while remaining hands-on in authoring and execution.
• Strong understanding of FDA regulations and product development processes.

Preferred

• Experience with electrophysiology, cardiology, catheter-based, or other electro-medical devices.
• Global regulatory submission experience.
• Knowledge of Quality Systems, Design Controls, and Risk Management.
• Experience in a small or growth-stage medical device company.
• RAC certification.

What We're Looking For

• Self-sufficient and highly accountable.
• Comfortable working in a fast-moving environment with shifting priorities.
• Strong collaborator with a roll-up-your-sleeves mentality.
• Able to balance strategic thinking with day-to-day execution.