Hill-Rom Regulatory Affairs Specialist in Batesville, Indiana
This position will be primarily responsible for preparation, submission and follow-up of global regulatory dossiers to support the introduction of Patient Support Systems (PSS) medical devices. Specific responsibilities will include:
Work with RA Director/ Manager to provide regulatory input to product lifecycle planning
Acquire and submit specific documentation to regional regulatory personnel to support global regulatory submissions, allowing marketing and sales of Hillrom products
Determine submission and approval requirements for Hillrom state licenses, monitor and submit monthly/annual updates
Assist Patient Support Systems (PSS) regulatory managers with documentation, as assigned
Review regulatory Intelligence databases on weekly basis to identify emerging issues, potential impact on Hillrom products
Minimum experience/Qualifications preferred:
Bachelor’s degree in a related medical, science, engineering services, quality or regulatory discipline. Demonstration of equivalent experience in another field acceptable.
2-4 years experience in the medical device field. Experience with international regulatory submissions for Medical Devices (Class I & II preferred), may consider quality management, or related area towards total years of experience.
Communicate effectively verbally and in writing
Communicate with diverse audiences and personnel
Write and edit technical documents
Work with cross-functional teams
Work with people from various disciplines and cultures
Review technical documents
Proficiency with Microsoft systems (Excel, PowerPoint, and Word); excellent English reading/writing skills; attention to detail; questioning and listening skills.
Primary Location: United States-Indiana-Batesville
Other Locations: United States-Illinois-Chicago, IL, United States-North Carolina-Cary
Posting Entity Hillrom
Req ID: 20124712