Description
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
The Principal, Regulatory Affairs Specialist supports new and sustaining product development teams and will work closely with cross functional team members to assist with regulatory issues related to such items as labeling, marketing claims and testing requirements. The Principal, Regulatory Affairs Specialist is an individual contributor and reports directly to the US Senior Manager of Regulatory Affairs.
Essential Duties & Responsibilities
- Plan, coordinate & prepare RA docs in support of new product development.
- Prepare 510(k) premarket notifications, pre-subs and IDE’s.
- SaMD and SiMD submission/support a plus.
- Construct and manage EU MDR technical files.
- Review product labeling including advertising & promotional materials for compliance.
- Manage registration plans through collaboration with global RA peers.
- Review & approve test compliance reports & associated tech documentation.
- Review scientific/engineering materials including protocols and test reports.
- Provide global performance & safety reqs as an input to product design teams.
- Provide regulatory assessment on proposed changes to marketed devices.
- Support international product registration regulatory colleagues.
Education, Experience and Qualifications
- Bachelor’s degree is required. Engineering, biology, or science related field preferred.
- Minimum 5 years’ experience in regulatory affairs. Advanced degree may be considered as partial fulfillment of experience.
- Experience with successful preparation of 510(k)’s and/or PMAs is required.
- Proven ability to contribute creative yet practical solutions to problems.
- Strong cross-organizational collaboration with internal stakeholders and external regulatory agencies.
- Strong project planning, leadership, negotiation, and presentation skills.
