Senior Specialist - Regulatory Affairs -Transfusion

Are you a highly experienced regulatory affairs professional with a passion for ensuring the safety and efficacy of transfusion products? Do you have a deep understanding of global regulatory requirements and a track record of successfully navigating complex regulatory environments? If so, we have an exciting opportunity for you to join our team at Abbott as a Senior Specialist in Regulatory Affairs for Transfusion. As a key member of our regulatory affairs team, you will play a critical role in ensuring our transfusion products meet all necessary regulatory standards while also helping to shape the future of our company. We are seeking a candidate with strong leadership skills, excellent attention to detail, and a demonstrated ability to work collaboratively with cross-functional teams. If this sounds like you, we encourage you to apply and join our mission to improve the lives of patients around the world.

1. Develop and maintain a deep understanding of global regulatory requirements related to transfusion products.
2. Ensure compliance with all relevant regulatory standards and guidelines.
3. Lead and manage all aspects of regulatory submissions and approvals for transfusion products.
4. Develop and maintain relationships with regulatory agencies and stay up-to-date on any changes or updates to regulations.
5. Collaborate with cross-functional teams, including R&D, quality, and clinical teams, to ensure regulatory compliance throughout the product development process.
6. Provide strategic guidance and direction to product development teams to ensure timely and successful regulatory submissions.
7. Conduct regulatory risk assessments and develop mitigation plans to address any potential issues.
8. Monitor and analyze regulatory trends and developments in the transfusion product industry.
9. Represent the company in external meetings and conferences related to regulatory affairs for transfusion products.
10. Mentor and train junior regulatory affairs team members.
11. Serve as a subject matter expert on all regulatory matters related to transfusion products.
12. Collaborate with internal and external stakeholders to develop and implement regulatory strategies for new and existing products.
13. Ensure all documentation and records related to regulatory submissions are accurate, complete, and filed in a timely manner.
14. Continuously assess and improve regulatory processes and procedures.
15. Stay current on industry best practices and proactively identify opportunities for process improvement.
16. Take a leadership role in advocating for patient safety and product efficacy within the company.
17. Communicate effectively with internal and external stakeholders about regulatory requirements and any updates or changes.
18. Uphold ethical and professional standards in all interactions and activities.
19. Stay updated on company policies and procedures related to regulatory affairs.
20. Participate in regulatory audits and inspections, as needed.

According to JobzMall, the average salary range for a Senior Specialist - Regulatory Affairs -Transfusion in Abbott Park, Green Oaks, IL, USA is $92,000 to $110,000 per year. This may vary depending on factors such as level of experience, education, and specific job responsibilities.

From removing the regular pain of finger sticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s blood donations to ensure a healthy supply, our purpose is to make the world a better place by bringing life-changing health technologies to the people who need them. That’s our commitment to helping you live your best life.