Regulatory Affairs Specialist

hace 1 día

España Nordberg Medical A tiempo completo

Regulatory Affairs Specialist – Medical Devices The Regulatory Affairs Specialist is responsible for preparing, submitting, and maintaining regulatory documentation to support global approvals of high‑risk or implantable medical devices. This role ensures compliance with U.S. FDA regulations, EU MDR 2017/745, and other international requirements, supporting product lifecycle management from development through post‑market surveillance. Department: Regulatory Affairs Reports To: Senior Regulatory Affairs Manager Key Responsibilities Prepare and submit regulatory documents such as IDEs, PMAs, PMA Supplements, Technical Documentation (per EU MDR), and global registrations (e.g., Canada, Japan, China, Australia). Ensure labeling, Instructions for Use (IFUs), and promotional materials meet regulatory requirements for Class III devices. Lead or support regulatory strategy development for new product introductions, design changes, and sustaining products. Maintain compliance with regulatory standards including FDA 21 CFR Parts 807, 812, 814, and EU MDR Annexes I–III, IX, X. Support the maintenance of Clinical Evaluation Reports (CERs), Risk Management documentation (ISO 14971), and Post‑Market Surveillance (PMS) activities. Collaborate with cross‑functional teams (R&D, Clinical, Quality, Marketing) to ensure regulatory requirements are met throughout the product lifecycle. Participate in internal audits, FDA inspections, and Notified Body assessments as the Regulatory SME. Monitor and communicate changes in global regulations and assess the impact on existing products and documentation. Maintain regulatory records, files, and tracking systems in accordance with company procedures and quality systems (ISO 13485, QSR). Skills and Requirements Qualifications Required Bachelor’s degree in Regulatory Affairs, Biology, Pharmaceutical, Life Sciences, or related field. 2+ years of regulatory affairs experience in the medical device industry, with at least 2 years supporting Class III devices. Strong working knowledge of U.S. FDA regulatory pathways (e.g., PMA, IDE) and EU MDR Technical Documentation requirements. Experience preparing regulatory submissions and responding to regulatory authority queries. Familiarity with ISO 13485, ISO 14971, and applicable international regulations (e.g., TGA, PMDA, NMPA). Strong project management, organizational, and communication skills. Preferred Experience with implantable devices. Experience with software used in documentation and submission preparation (e.g., regulatory databases). Personality Independent: You are independent in organizing your daily tasks, able to manage your work in a remote setting. Detail‑oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task to ensure compliance. Resilient and adaptable: You bring a resilient, can‑do attitude and demonstrate persistence when facing challenges. Collaborative: You have strong interpersonal and communication skills to effectively collaborate with internal teams and external stakeholders. Seniority level Mid‑Senior level Employment type Full‑time Job function Legal #J-18808-Ljbffr

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