Senior Specialist, Regulatory-Medical Device (Remote/Virtual) - Full-time / Part-time

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. 

Front Line Care (FLC) is a business unit of Hillrom focusing on medical devices that enable earlier diagnosis and treatment. The sooner the diagnosis—the more options for effective treatments. Our smart screening devices and diagnostic tools empower clinicians and health systems to identify and treat every patient with confidence, shortening the path to assessment and then to care. The FLC portfolio includes products for vision screening & diagnostics which focus on preventing blindness by facilitating early detection and treatment; physical exam & diagnostic tools; diagnostic cardiology connected electrocardiograph products; and respiratory care devices.

The Sr Regulatory Affairs (RA) Specialist is responsible to build and deliver on regulatory strategies and technical documentation to support regulatory submissions in US, Canada and EU for Front Line Care medical devices. This individual will collaborate closely with other regulatory experts in these markets or other regulatory experts in other markets to achieve the best possible outcomes for effective product registration. This individual is responsible for a broad range of products in the Front Line Care portfolio.  The Sr RA 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 Sr RA Specialist is an individual contributor and reports directly to the US Manager of Regulatory Affairs.

Essential Duties & Responsibilities

• Plan, coordinate and prepare regulatory documents in support of new product development


• Prepare 510(k) premarket notifications, pre-subs and IDE’s


• Construct and manage EU MDR technical files


• Review product labeling including advertising and 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

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

Travel: Less than 5%

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.
                                                                                                                                                               

 

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 here and let us know the nature of your request along with your contact information.

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