Regulatory Affairs Specialist

Senior / Principal Regulatory Affairs Specialist Job Description We are seeking a hands‑on Senior / Principal Regulatory Affairs Specialist to support regulatory strategy and submissions for complex Class II and Class III medical devices. This person will work closely with R&D, Quality, Manufacturing, and Clinical teams to support products through development, regulatory submission, design changes, and commercialization. The ideal candidate has direct experience with FDA submissions for active, invasive, electromechanical, electronic, or software‑enabled medical devices. This is not a documentation‑only role; the successful candidate will be comfortable discussing technical product changes with engineers and translating them into clear regulatory strategies and submission content. Day‑to‑Day Responsibilities Lead and author FDA regulatory submissions and lifecycle activities, including PMA supplements, IDEs, Q‑Submissions/Pre‑Subs, annual reports, real‑time supplements, and deficiency responses. Develop regulatory strategies for product development, design changes, manufacturing changes, and post‑market activities. Partner directly with R&D, Quality, Manufacturing, Clinical, and Engineering teams on technically complex product issues. Review and contribute to technical documentation, verification and validation evidence, risk documentation, labeling, and change‑control records. Assess regulatory impact of software, hardware, manufacturing, labeling, and system‑level product changes. Support FDA inspections, audits, CAPAs, recalls, and other quality‑system activities as needed. Support international registrations and EU MDR activities when required, including Technical Documentation, labeling, and notified‑body interactions. Requirements / Qualifications Required Bachelor’s degree in Biomedical Engineering, Engineering, Science, or a related technical discipline. 5+ years of medical device regulatory affairs experience. Direct experience authoring or leading FDA submissions for Class II and/or Class III medical devices. Experience with PMA supplements, IDEs, Q‑Submissions/Pre‑Subs, FDA deficiency responses, annual reports, or similar FDA submission activities. Experience supporting active, invasive, electromechanical, electronic, software‑enabled, or other technically complex medical devices. Ability to work directly with R&D and engineering teams on product design, verification/validation, design changes, and manufacturing changes. Strong regulatory writing, communication, and project ownership skills. Experience supporting audits, inspections, CAPAs, recalls, or post‑market regulatory activities. Preferred Experience with defibrillation/resuscitation, cardiac devices, surgical robotics, catheter‑based devices, electrophysiology, capital equipment, or Class III devices. Experience with FDA PMA products and real‑time or manufacturing site change supplements. Experience with global registrations, including Health Canada, EMEA, APAC, or LATAM. EU MDR Technical Documentation or notified‑body experience. Familiarity with ISO 13485, ISO 14971, IEC standards, software documentation, and risk management. Experience reviewing promotional or advertising materials. #J-18808-Ljbffr