Senior Specialist, Regulatory Data Management - Integra LifeSciences
Salt Lake City, UT
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
The Senior Specialist, Regulatory Data Analyst is a seasoned professional leading the ongoing development, maintenance, and expansion of the Regulatory Information Management System (RIMS), as well as other software platforms that support the global regulatory affairs (GRA) function as well as other functions within Integra. The role requires an understanding of data platform development, data verification protocol development, data manipulation, and basic programming skills. It also requires a functional understanding of regulatory affairs processes, US and OUS regulatory requirements, and the US FDA Quality Management System regulation. The role will act as a liaison between the GRA and IT functions to ensure that platform requirements are integrated appropriately into system development.
This position must be able to work independently as well as manage/collaborate with cross functional team members for projects.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential job duties and responsibilities include, but are not limited to:
+ Provide direct involvement with the verification and development of the RIMS system as well as support for RIMS users in all regions.
+ Understand the requirements of Unique Device Identification (UDI) regulations for on-going global compliance (e.g., FDA GUDID, EUDAMED). Establish RIMS dashboards and reporting to track key department activities, data trending, and metrics; provide system reports to regulatory colleagues and other stakeholders, when requested.
+ Obtain, review, organize and interpret data from regulatory documents and submissions for entry into the RIM system.
+ Collaborate with IT, Product Development, Quality, and Global RA on business requirements for Integra software systems.
+ Develop a deep understanding of the system functionality and regulatory requirements to support regulatory processes.
+ Support other digital platforms within Integra as needed, which may include Veeva platforms, Oracle, Agile, and/or Trackwise.
+ Develop and maintain style guides, templates, standard operating procedures, and work instructions related to the RIM system as well as other Regulatory Operations activities including training on those processes as well as refresher training.
+ Stay apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact data within the digital platforms. Perform other relevant duties as assigned.
QUALIFICATIONS
+ Bachelor's degree with 5+ years of experience or equivalent years of total experience, high school diploma or equivalent required.
+ Certified Information Professional (CIP) preferred.
+ Minimum of 5 years' experience working in database management in a healthcare setting.
+ Demonstrates excellent writing, Excel, PowerPoint, Microsoft Office Suite, multi-tasking, problem solving and communication skills.
+ Strong understanding and capability in change management, database analytics and development including data uploads, data identification, data formatting and data verification procedures.
+ Familiarity with reading and interpreting regulatory data or similar technical information and extraction of data.
+ Ability to work collaboratively across functions in a matrixed organization.
+ Excellent attention to detail and organizational skills.
+ Utmost discretion with confidential information.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
The Senior Specialist, Regulatory Data Analyst is a seasoned professional leading the ongoing development, maintenance, and expansion of the Regulatory Information Management System (RIMS), as well as other software platforms that support the global regulatory affairs (GRA) function as well as other functions within Integra. The role requires an understanding of data platform development, data verification protocol development, data manipulation, and basic programming skills. It also requires a functional understanding of regulatory affairs processes, US and OUS regulatory requirements, and the US FDA Quality Management System regulation. The role will act as a liaison between the GRA and IT functions to ensure that platform requirements are integrated appropriately into system development.
This position must be able to work independently as well as manage/collaborate with cross functional team members for projects.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential job duties and responsibilities include, but are not limited to:
+ Provide direct involvement with the verification and development of the RIMS system as well as support for RIMS users in all regions.
+ Understand the requirements of Unique Device Identification (UDI) regulations for on-going global compliance (e.g., FDA GUDID, EUDAMED). Establish RIMS dashboards and reporting to track key department activities, data trending, and metrics; provide system reports to regulatory colleagues and other stakeholders, when requested.
+ Obtain, review, organize and interpret data from regulatory documents and submissions for entry into the RIM system.
+ Collaborate with IT, Product Development, Quality, and Global RA on business requirements for Integra software systems.
+ Develop a deep understanding of the system functionality and regulatory requirements to support regulatory processes.
+ Support other digital platforms within Integra as needed, which may include Veeva platforms, Oracle, Agile, and/or Trackwise.
+ Develop and maintain style guides, templates, standard operating procedures, and work instructions related to the RIM system as well as other Regulatory Operations activities including training on those processes as well as refresher training.
+ Stay apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact data within the digital platforms. Perform other relevant duties as assigned.
QUALIFICATIONS
+ Bachelor's degree with 5+ years of experience or equivalent years of total experience, high school diploma or equivalent required.
+ Certified Information Professional (CIP) preferred.
+ Minimum of 5 years' experience working in database management in a healthcare setting.
+ Demonstrates excellent writing, Excel, PowerPoint, Microsoft Office Suite, multi-tasking, problem solving and communication skills.
+ Strong understanding and capability in change management, database analytics and development including data uploads, data identification, data formatting and data verification procedures.
+ Familiarity with reading and interpreting regulatory data or similar technical information and extraction of data.
+ Ability to work collaboratively across functions in a matrixed organization.
+ Excellent attention to detail and organizational skills.
+ Utmost discretion with confidential information.
Source : Integra LifeSciences
