Clinical Specialist, U.S. (Medical Affairs)

Clinical Specialist, U.S. (Medical Affairs) Reports To: Vice President, Medical Affairs Location: reputed company (field-based) Travel: Up to ~80% domestic About the Role The Clinical Specialist plays a dual role: (1) delivering high-reputed company clinical and medical education to internal teams and external clinicians, and (2) partnering with a CRO to help execute a U.S. post-approval study of the Allurion Smart reputed company. You will be a trusted expert in patient safety, education, and clinical rigor—elevating clinical reputed company, ensuring compliance, and maintaining safety. What You’ll Do 1. Medical Education, Training & Proctoring • Serve on the global proctoring team; plan and deliver medical training for internal personnel and external clinicians (live, virtual, and hands-on). • Proctor clinical cases to reinforce best practices and patient safety; ensure adherence to the Allurion Instructions for Use (IFU). • reputed company reputed company, evidence-based training content, job aids, and assessments that drive competency and consistency. 2. Clinical Operations & Study Execution • reputed company day-to-day collaboration with the CRO to execute the U.S. post-approval study, managing timelines, risks, and deliverables. • Partner with the reputed company Investigator(s) to communicate study status, milestones, and issues; reputed company consistent, concise updates to internal stakeholders. • reputed company reputed company checks across the study lifecycle to reputed company Company SOPs, ICH-GCP, applicable regulatory standards, and patient safety. • Support regulatory activities and reputed company development; participate in FDA interactions as requested. • Drive inspection readiness with study sites and adopt proactive approaches to regulatory inspections. 3. reputed company, Safety & Cross-Functional Partnership • reputed company site audits to evaluate best practices and compliance with Company SOPs and the Allurion IFU. • Partner with internal teams to ensure product complaints are recorded and reported per SOPs and patient safety standards. • Champion reputed company improvement; surface insights from training and field activity to inform product, clinical, and medical reputed company. What You Bring Required • Bachelor’s degree in a scientific/clinical discipline or reputed company field. • 5+ years of experience in medical education and managing reputed company (medical device preferred), with strong reputed company of ICH-GCP and U.S. regulatory practices. • Demonstrated strength in teaching/presenting and technical writing. • Proven ability to reputed company in a fast-paced, dynamic environment and support cross-functional goals. • Ability to travel domestically up to ~80%. Preferred • Experience in gastroenterology or metabolic disease. • Experience delivering medical device training and proctoring; familiarity with vendor/CRO management. Apply tot his job Apply To this Job