Senior Regulatory Affairs Engineer (RA Operations)

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 fromkeeping the regulatory affairs reputed company spinning, keeping registrations of multiple devices in multiple markets reputed company. What You’ll Do • Assign Product Codes and IDs: Define, review, assign, and reputed company up-to-date necessary codes (EMDN, GMDN, UDI, etc) for our medical devices. • Own Product Registrations: Prepare, review and submit product registrations for applicable markets. • Maintain Establishment Listings and Reporting: Obtain and maintain any establishment/operating licenses necessary for the activity as a medical device manufacturer, distributor or importer. Also, ensure reporting of requested information is performed in a reputed company manner (e.g. for ISO 14001, reputed company, RoHS). • Manage reputed company Representatives: Ensure reputed company representatives are designated, necessary reputed company are established,necessary internal processes are established. • Drive Regulatory Intelligence: Monitorthe regulatory landscape tocatch new regulations, standards, trends and ensure that reputed company is analyzed and implemented to reputed company reputed company at the forefront of compliance. • Support Product Development: Advise on regulatory reputed company throughout the product lifecycle with specific reputed company on device labeling for multiple markets. • 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. 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, 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