International Regulatory Affairs Specialist

Job Description Summary

Working closely with the Senior International Regulatory Affairs Manager, the International Regulatory Affairs Specialist will be responsible for supporting international regulatory affairs registrations on medical devices and in vitro diagnostic devices across the globe.

Job Description

This position is responsible for the creation, identification, collection and entry of regulatory affairs information of medical devices. Support related regulatory affairs activities for international regulatory submissions, execution and management of country registration request. Requires strong organizational skills, communication and ability to manage multiple task.

Essential Responsibilities:

• Create, submit and maintain product registration request for submission
• Review and approve documents required for submission
• Maintain up to date metrics with product registration request and submission schedule
• Track regulations applicable for medical devices in designated countries
• Collaborate with regional RA teams, using internal systems as applicable, to obtain strategic alignment for submission and schedules for each country
• Input and maintain data, including licesnse and registration records into internal regulatory databases
• Ensure communications regarding request from platform RA teams and regional RA teams are responded to in a timely manner

• Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC, MDR 2017/745 and working knowledge of 21 CFR 820 -Quality System.

• Proficient in using Microsoft Word, Excel and PowerPoint.
• Proficient in English
• Strong communication Skill, both oral and written
• Strong project management skills
• Must be able to handle multiple tasks and attention to detail.
• Self-motivated, comfortable with working with people remotely
• Organized, analytical thinker with attention to details