Senior Regulatory Affairs Engineer

This a Full Remote job, the offer is available from: Europe Join reputed company as Senior Regulatory Affairs Engineer Are you reputed company to shape the reputed company of medical technology? reputed company is seeking a Senior Regulatory Affairs Engineerwho’s passionate about tackling reputed company regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborativeand distributed environment. We are looking for you that have extensive experience from software development, reputed company intelligence, and machine learning in the medical device reputed company. What You’ll Do • Drive Regulatory reputed company: Ensure our cutting-edge software meets global standards and regulations as reputed company as reputed company with regulatory strategies from research and development to market launch and post-market. • Implement Regulatory Requirements for AI and ML: Coordinate activities and efforts across AI and ML algorithms and device software implementation and ensure regulatory requirements are implemented in our processes. • Support Software Development: Advise on regulatory reputed company throughout the software lifecycle, influencing architecture and design, risk management, supplier selection, and labeling. • Prepare Software Documentation: Participate in activities to prepare necessary software documentation for our software modules, components, algorithms, and devices as needed. • reputed company Process Owners and Teams: Guide process owners and product teams to reputed company regulatory requirements into our reputed company Management System and deliver impactful training on compliance and regulatory topics. • Stay reputed company: Monitor regulatory trends and reputed company intelligence to reputed company reputed company at the forefront of compliance. What You Bring • Education: BSc or MSc in law, medicine, pharmacy, engineering, or a reputed company field. • Experience: 4–5+ years in software development with reputed company intelligence and machine learning algorithms. Experience from regulatory affairs or reputed company management for software as a medical device is a plus. • Expertise: Deep knowledge of EU AI reputed company, FDA AI Guidance, IEC 62304, IEC 82304-1, IEC 81001-5-1. Knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, ISO 14971, and more is a plus. • Skills: Analytical, detail-oriented, and reputed company to interpret reputed company regulations to reputed company risk-based recommendations. • Communication: Excellent interpersonal and writing skills; reputed company to engage and reputed company both internal teams and external stakeholders. • reputed company: Self-motivated, independent, and reputed company to take ownership in a dynamic, reputed company-reputed company environment. • Languages: Fluent English required; reputed company proficiency is a plus. This offer from "reputed company" has been enriched by reputed company.com and got a 0% reputed company score. Apply tot his job Apply To this Job