Manager, Regulatory AffairsReq # JR - 040352 Location Round Lake, Illinois, United States Job Category Regulatory Affairs Date posted 05/12/2021
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.
As a Manager - Global Regulatory Affairs, you will be responsible for defining global regulatory strategies and preparing submissions in support of new and existing marketing authorizations for medical devices, focusing on software, for the Medication Delivery global business unit (GBU).
You will interface with key business and cross-functional stakeholders to ensure that the commercial objectives are achieved. Specific activities may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project teams.
This is an important individual contributor position within the Medication Delivery Regulatory Team and you will be accountable for the relationship with the US Food and Drug Administration and Notified Body for assigned products. You will provide input and help influence global regulatory strategies and be responsible for the local execution of Baxter’s regulatory initiatives in line with business goals.
- Develop and execute regulatory strategies for Baxter’s Patient Monitoring platform and for complex projects including new product development and maintenance of licenses/authorizations for existing marketing authorizations including development of sound regulatory decisions and justifications
- Ensure regulatory strategies are aligned with business objectives and project scope
- Represent and lead the RA function on assigned cross-functional project teams
- Prepare and submit pre-subs, 510(k)s, and De Novo requests according to FDA guidelines
- Create and maintain EU STED and Declaration of Conformity Files according to MDR
- Excellent writing skills to develop clear and logical information and conclusions based on design documentation
- Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
- Effectively communicate with peers and functions at the project level, within RA and with different levels of management
- Manage and interface with external regulatory consultants
- Mentor and coach individuals within RA
- Successful preparation and submission of 510(k) and international registrations
- Scientific and sound regulatory knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills
- Ability to independently identify compliance risks and escalate when necessary
- Ability to lead and coach others
Education and Experience
- Bachelor’s degree in a scientific discipline, engineering preferred
- 5 years regulatory experience with knowledge of physiological monitoring devices including algorithms and sensor technology, device interoperability and software development lifecycle
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.
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