Senior Regulatory Affairs Specialist (Remote)Req # 21126021 Location United States (Remote) Additional locations Columbus, Ohio; New York (remote); Delaware (remote); New Jersey (remote) Job Category Regulatory Affairs Date posted 08/05/2022
This is where you save and sustain lives
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 RA Sr. Specialist supports Global expansion, 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 a global expansion strategy, registration, labeling, marketing claims, and testing requirements. The RA Sr. Specialist is an individual contributor and reports directly to the Sr. Manager of Global Regulatory Affairs.
Essential Duties & Responsibilities
- Plan, coordinate & prepare all regulatory documents in support of all new product development
- Prepare Global Registration Strategies and Documentation
- Construct and manage Global Emerging Market Expansion
- Review product labeling including advertising & promotional materials for compliance
- Manage registration plans through collaboration with global RA peers
- Review and approve test compliance reports and associated technical documentation
- Review scientific/engineering materials including protocols and test reports
- Provide global performance and safety requirements as an input to product design teams
- Provide regulatory assessment on proposed changes to marketed devices
- Support international product registration regulatory colleagues
- Bachelor’s degree is required. Engineering, biology, or science related field preferred.
- Minimum 3-5 years’ experience in regulatory affairs. Advanced degree may be considered as partial fulfillment of experience.
- Experience with successful preparation of global registration
- Proven ability to contribute creative yet practical solutions to problems
- Strong cross-organizational collaboration with internal stakeholders and external regulatory agencies
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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.
EEO is the Law
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