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. #J-18808-Ljbffr