Senior Specialist, Regulatory Affairs

Are you a highly skilled and experienced Regulatory Affairs professional looking for an exciting new opportunity? Baxter International is seeking a Senior Specialist to join our dynamic team and play a critical role in ensuring our products comply with all regulations and guidelines. As a global leader in healthcare, Baxter is committed to improving the lives of patients around the world through innovative and life-saving products. In this role, you will have the opportunity to utilize your expertise and contribute to the success of our company. If you are a detail-oriented and proactive individual with a strong understanding of regulatory requirements, we encourage you to apply for this position. Join us in making a meaningful impact in the healthcare industry.

1. Ensure compliance with all applicable regulations and guidelines for Baxter's products.
2. Stay up-to-date on changes and updates to regulatory requirements and communicate them to relevant teams.
3. Review and interpret regulatory guidelines to ensure accurate and timely submissions.
4. Collaborate with cross-functional teams to develop and implement strategies for regulatory compliance.
5. Prepare and submit regulatory submissions, including premarket notifications, registrations, and other required documentation.
6. Manage and maintain product registrations and licenses.
7. Conduct risk assessments and develop risk management plans for new and existing products.
8. Provide regulatory support for product development, including reviewing and approving product labeling, promotional materials, and clinical studies.
9. Participate in internal and external audits to ensure compliance with regulatory requirements.
10. Serve as a subject matter expert on regulatory affairs for Baxter products.
11. Train and mentor junior regulatory affairs staff.
12. Monitor and track regulatory changes and assess their impact on Baxter's products.
13. Collaborate with regulatory agencies as needed.
14. Continuously improve processes and procedures to ensure efficiency and compliance.
15. Represent Baxter in industry meetings and conferences related to regulatory affairs.
16. Adhere to company policies and procedures and maintain a high level of professionalism at all times.
17. Contribute to the overall success and growth of Baxter as a global healthcare leader.

According to JobzMall, the average salary range for a Senior Specialist, Regulatory Affairs in Deerfield, IL, USA is approximately $90,000 to $120,000 per year, with a median salary of $105,000. This can vary depending on factors such as experience, education, and specific job responsibilities.

Baxter International Inc. is a Fortune 500 American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions.