What Regulatory Affairs Data Management contributes to Cardinal Health
Data Management Regulatory Affairs Principal Specialist focuses in project leadership for maintaining global regulatory compliance by supporting the development and implementation of regulatory processes, systems, and databases (data entry and remediation, technical review of data, and the use of automated tools for reporting and analysis).
Data Management RA Principal Specialist is a detail-oriented and proactive individual that will assist in ensuring regulatory compliance across global markets. This role supports the development, implementation, and maintenance of regulatory processes, systems, and databases. The ideal candidate will possess strong data management skills, experience with regulatory submissions (GUDID, EUDAMED, etc.), and a passion for continuous improvement in a dynamic regulatory environment. The job will serve as a mentor for less experienced co-workers.
Join our team as a Data Management RA Principal Specialist and play a key role in supporting product lifecycle management and global regulatory compliance. This position involves leading projects independently, performing technical reviews of data, and utilizing automated tools (Power BI, Excel, SQL) to enhance reporting and analysis efficiency. The successful candidate will contribute to process improvements and support various regulatory activities, including labeling review, website updates, and audit preparation.
Responsibilities
Assist in development and/or implementation and/or maintenance of regulatory processes & procedures, systems, databases and reporting mechanisms/tools to ensure they are in compliance with global regulations/guidance’s/ standards and in alignment with overall business strategic goals and priorities
Assist in technical review of data or reports in support of product life cycle management and regulatory submissions for GUDID, EUDAMED etc
Data entry, remediation, and maintenance of various regulatory databases and internal systems
Assist in regulatory operations various activities like: review of product labeling, Instructions For Use (IFUs), and Declaration of Conformities (DoCs) upload to website, creation of regular reporting for compliance with global regulations, support of document update for global market submissions, external and internal audit support, etc.
Applies usage of automated tools for reporting and analysis efficiency (Power BI, advanced Excel, SQL, etc)
Assist with regulatory compliance improvements in collaboration with internal regulatory function and cross functional teams
Assist in business process support for IT applications/systems that digitally enable regulatory compliance
Assists manager to define deliverables, establish target timelines and assign responsibilities on related data management projects.
Assist manager on reviewing monthly performance indicators for report-out
Leads projects independently with minimum guidance from the manager
Qualifications
4-6 years of experience in data analysis, regulatory or equivalent role to include
Bachelor's degree in science, health science, biotechnology, or similar field
English: Advance fluency
Spanish: Advance fluency
Solid experience in data analytics
Advance knowledge of Excel, Word, Power Point. Knowledge of PowerBi preferred.
Strong partnership skills and ability to work in a matrix environment.
What is expected of you and others at this level
Applies comprehensive knowledge and a thorough understanding of regulatory concepts and principles to perform varied tasks and projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems
Solutions are innovative and consistent with organization objectives
Completes work on time; works independently and receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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