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Hill-Rom Regulatory Affairs Specialist in Batesville, Indiana

Description

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

Qualifications

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.

Communication Skills:

  • 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.

Job: Regulatory

Primary Location: United States-Indiana-Batesville

Other Locations: United States-Illinois-Chicago, IL, United States-North Carolina-Cary

Schedule Full-time

Travel No

Posting Entity Hillrom

Req ID: 20124712

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