Principal Specialist, Regulatory Affairs San Ġwann tal-Għargħar, San Ġwann

Job description

Principal Specialist, Regulatory Affairs Req # 211681 Location San Ġwann tal-Għargħar, San Ġwann, Malta Job Category Regulatory Affairs Date posted 10/23/2026 Apply Now This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Job Description We are looking for a Principal Specialist, Regulatory Affairs to join our team in Malta. This role resides within the Regulatory Operations - Systems organization. This function will partner with Global IT (GIT) and Global Regulatory Affairs (GRA)/Global Business Segments to: Create strategy to identify changes to procedures/processes across Global Regulatory Affairs and ensure implementation of procedures and processes for the Global Regulatory function. Provide metrics to ensure compliance to requirements, identify gaps and escalate as needed. Lead and support PromoMats, RIM and other RA systems Participate in system upgrades to assure integrity of data is maintained. Run and revise UAT Test scripts partnering with GIT for the most efficient solutions. Verify the maintenance of support systems, libraries, and dictionaries. Maintain awareness of regulatory requirements and evaluate potential impact to Baxter. Lead and participate in system projects and process requests to maintain data accuracy Responsible for establishing data Governance for RA systems Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. 3-5 years of experience in Regulatory Affairs, preferably within the MedTech or pharmaceutical industry Ability to work in RIM (Regulatory Information Management System) Technical system skills (e.g. word processing, spreadsheets, databases, online research) Experience with SharePoint 2010 and Excel will be an advantage. Strong written and verbal communication skills Knowledge of Veeva Systems Excellent organization skills and ability to support multiple projects Work independently with minimal direct supervision Strong negotiation and collaboration skills Ability to independently identify compliance risks and resolve or escalate when necessary Experience in addressing complex problems or processes We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The minimum salary for this position is €36.800 annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice . Apply Now Address Explore this location Triq San Giljan San Gwann SGN3000 Malta Explore This Location Share LinkedIn Facebook X Email Related Content Employee Benefits Our comprehensive benefits options reflect the value we place in our employees. Learn More March 28, 2024 People of Baxter Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world. These are our stories. Learn More March 28, 2024 Read Time: 5 min. 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Begin your exploration by visiting this page to learn more about our career areas and how your work can be part of our mission to save and sustain lives. Learn More March 05, 2024 5 Minute Read Related Content - SR_JD Our Stories - Hub Related Content - Culture Employee Stories Career Advice Article Life At Baxter Blog Explore our blog and read the stories of our talented employees, the impact of our work, and our unique, vibrant culture. Here, you can learn about the work that empowers our colleagues to make a difference and drives our mission to save and sustain lives. Learn More December 04, 2024 Related Content - SR_JD Related Content - Culture Our Locations | Careers at Baxter At Baxter, we are driven not by what is easy, but what is possible. Learn more about our different locations and view available jobs within them here. Learn More November 13, 2024 Engineering Careers at Baxter Make a lasting impact on lives worldwide by joining Baxter's Engineering team, wh