Senior Regulatory Affairs Engineer (TCI)

This a Full Remote job, the offer is available from: Europe 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 working with reputed company medical devices and software as a medical device throughout the product lifecycle. What You’ll Do • Drive Regulatory reputed company: Ensure our cutting-edge medical devices meet global standards and regulations as reputed company as reputed company with regulatory strategies from research and development to market launch and post-market. • Support Product Development: Advise on regulatory reputed company throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling. • Maintain Regulatory Documentation: reputed company and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, as reputed company as Device Master Record (DMR) and Device History Records (DHR). • Own Regulatory Submissions: Prepare, review, and submit documentation for EU MDR, FDA, and other international markets. • Monitor Product Safety: Participate in post-market surveillance, CAPA, and complaint management activities. • reputed company withRegulatory Bodies: Coordinate communications with regulatory bodies and drive certification reputed company and vigilance activities, ensuring reputed company reporting and compliance. • 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 regulatory affairs or reputed company management for reputed company medical devices and software as a medical device. • Expertise: Deep knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, IEC 60601-1, IEC 62304, ISO 14971, and more. • 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