Hill-Rom Regulatory Specialist, UDI in Batesville, Indiana
Title: Regulatory Specialist, UDI
Location: United States-Indiana-Batesville
The Regulatory Affairs Specialist, UDI, will provide domestic and international regulatory affairs support as a superuser of the systems which hold attribute data concerning Hill-Rom medical devices in compliance with Unique Device Identification directives. This position will report to the Director, Regulatory Affairs.
Essential Duties and Responsibilities:
Classification, contribution of regulatory data, and confirmation of unique device identification attributes
Monitoring the upload and generation of GTIN and attribute data within the existing programs such as LANSA, OneWorldSync, and GUDID databases.
Generation and maintenance of documentation and procedures relating to UDI within our quality systems
Ensure compliance with regulations (21 CFR 820), standards specific to bar code or data matrix labeling or any other standard which should relate to UDI, and the quality manual
Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and help streamline data from project teams as required
Assist in the maintenance of regulatory files in a format consistent with requirements
Assist in development regulatory strategies as required; identify deliverables needed, co-ordinate with the business and technical and manufacturing groups to create submission content for identified products
Review documents, including but not limited to labeling
Thorough knowledge and understanding IT systems, validations of such, and data compilation
Consideration will be given to candidates who possess medical device regulations and standards knowledge, including but not limited to QSR, CMDR, Medical Device Directive, ISO Quality System and other applicable industry compliance standards.
Verbal and written communication skills, to include attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas of business.
The proven ability to prioritize and manage multiple projects and meet deadlines.
Must have the ability to work in both a collaborative (team) environment as well as perform independent work.
Strong appreciation of the impact of regulatory bodies on medical device product lifecycle.
Experience working with diverse cultures and employees.
May involve minimal bending and lifting.
Education and Experience:
Bachelor’s degree in a related medical, science, engineering services, or regulatory discipline.
Demonstrated strong proficiency with LANSA, One World Sync, Microsoft systems such as Excel, PowerPoint, and Word as well as Sharepoint, Access, and Cognos.