Quality Assurance and Regulatory Affairs Specialist (12-months fixed term contract) Istanbul, Istanbul

Job description

Req # 211332 Location Istanbul, Istanbul, Turkey Job Category Quality Date posted 10/08/2026 Apply Now Overview This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. Support for Parents Continuing Education/ Professional Development Employee Health & Well-Being Benefits Paid Time Off 2 Days a Year to Volunteer Success Profile What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit. Detail Oriented Continuous Learner Courageous Collaborative Critical Thinker Influential Quality Assurance and Regulatory Affairs Specialist (12-months fixed term contract) 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. Summary As a Quality Assurance and Regulatory Affairs Specialist, you will ensure compliance with quality and regulatory requirements by managing complaints, field actions, CAPAs, product release activities, and training programs. You will also maintain product registrations and regulatory authorizations, coordinate submissions, and support product launches and commercialization activities throughout the product lifecycle. Note: The selected candidate will be employed by an external company. What you'll be doing Complaint Management: Be Local Complaint Coordinator (LCC). Notify the authorities of all reportable Complaints. Field Action Management: Be FA Contact Person ensuring Implementation of FAs according to Baxter procedures and applicable regulations. Ensure back up for FCA Contact Person in the country are appropriately trained and back up are always available. Training: Train employees (including new SOP’s), ensure training records are maintained and archived. Assure that distributors, suppliers and service providers are trained on Baxter requirements. CAPA Management: Manage Non-Conformity Reports and CAPA. Release of Products: Perform release of products for distribution in accordance with the applicable procedures and local requirements. Selling Authorization: Perform selling authorization in accordance with the applicable procedures for Turkey. Regulatory document and submission: Develop and execute regulatory plans for the projects including new products and maintenance of licenses/authorizations for existing marketing authorizations. Coordinate regulatory activities to support product launches and ongoing commercialization efforts. Ensure regulatory documentation is complete, accurate, and submitted within required timelines. Maintain product registrations and licenses throughout the product lifecycle. What you'll bring The function requires a bachelor's degree in Pharmacy, Chemistry or Chemical Engineering degree is preferrable. For a person with the specified education at least 2 years of professional experience in Quality Assurance and/or Regulatory Affairs in a Pharmaceutical/ Medical device or relevant industry is required. Experience as delegated QP (Qualified Person) is preferrable. Knowledge of GMP; GDP; ISO9001 and ISO 13485 is preferrable. Ability of understanding country specific regulations and general quality requirements. Very good spoken and written English. Strong communication and problem solving skills and follow-up actions. Ability to work cross-functionally and independently. Computer skills (Word, Excel, Power Point, Outlook, corporate software). Good organizational and time management skills. 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 Istanbul Sun Plaza Kat:25 Maslak Sariyer İstanbul Türkiye Explore This Location Share LinkedIn Facebook X Email Hear from Our Employees 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. Meet Christelle, Senior Quality Manager in Malta “I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.” Meet Lorena, Senior QA Associate in London, UK “I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.” Meet Gary, Quality Research Manager in Singapore “I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.” 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. Our Stories - Hub Employee Stories Article Meet Yukinari Kono, GM of Kidney Care Japan Yukinari Kono, GM of Kidney Care Japan, leverages sales, marketing, and finance expertise to drive success and inspire team confidence. Learn More June 14, 2024 Baxter Manufacturing in Skaneateles Falls, NY The Skaneateles Falls Site is a leading manufacturer of medical devices and solutions, with a focus o