Principal Regulatory Affairs Specialist

Cardinal Health, Inc.; Lombardia; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading company is seeking a Data Management RA Principal Specialist to ensure global regulatory compliance. This role involves project leadership, technical data review, and use of automated tools for reporting. The ideal candidate will have strong data management skills and relevant regulatory experience.

Competenze

• 4-6 years of experience in data analysis or regulatory role.
• English and Spanish: Advanced fluency.
• Solid experience in data analytics.

Mansioni

• Maintain regulatory processes and compliance systems.
• Perform technical reviews and support regulatory submissions.
• Lead projects independently with minimal guidance.

Conoscenze

Data analysis

Strong partnership skills

Formazione

Bachelor's degree in science, health science, biotechnology

Strumenti

Excel

Power BI

SQL

Descrizione del lavoro

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.