Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist – Medical Devices

Location: Pittsburgh, PA | HybridSalary: $100,000–$130,000The OpportunityWe are looking for an experienced Senior Regulatory Affairs Specialist to join a growing medical device company developing innovative implantable technologies.This is a highly visible, hands-on position where you will act as the right hand to the RA/QA Director, taking on significant responsibility across regulatory strategy, submissions and cross-functional projects.You will join a small, experienced and highly collaborative Quality & Regulatory team and work closely with R&D, Quality, Manufacturing and Clinical colleagues.

With regulatory activities managed largely in-house, you will have the opportunity to work across the full product lifecycle.For someone ambitious, the position also offers significant room for growth, including the potential to develop into a regulatory management role and build a team as the company continues to expand.What You’ll Be DoingSupport and drive regulatory strategies for new and existing medical devices.Prepare and manage FDA pre-submissions and 510(k) submissions.Contribute to PMA activities and regulatory activities supporting clinical trials.Support EU MDR submissions and certification activities.Provide regulatory guidance to R&D, Quality, Manufacturing and Clinical teams.Determine regulatory requirements, testing needs and applicable standards.Support regulatory activities throughout product development and commercialization.Monitor changes to FDA, EU and international regulatory requirements.Participate in risk management activities, audits and inspections.Work cross-functionally to find practical solutions to regulatory challenges.Serve as a key regulatory partner to the RA/QA Director and take ownership of important projects and deliverables.What We’re Looking ForApproximately 6–9+ years of Regulatory Affairs experience within the medical device industry.Strong hands-on experience with FDA submissions, particularly pre-submissions and 510(k)s.Experience with or strong exposure to PMA pathways and clinical-stage medical devices.Working knowledge of EU MDR and experience supporting European regulatory submissions or certification.Knowledge of FDA regulations, ISO 13485 and relevant medical device standards.Additional international regulatory experience is highly valued.Bachelor's degree in Engineering, Life Sciences or another relevant discipline.The PersonYou are a proactive, hands-on and collaborative regulatory professional who takes ownership, works well cross-functionally and thrives in a fast-moving environment.Why Join?Work directly as the right hand to the RA/QA Director.Significant responsibility and cross-functional exposure.Supportive, experienced QA/RA team.Strong growth potential, including a possible path into management.$100,000–$130,000 base salary.Hybrid flexibility with regular on-site collaboration.