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Regulatory Affairs Manager - SaMD

Req # JR - 037047 Location Round Lake, Illinois, United States Job Category Regulatory Affairs Date posted 11/30/2021

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 Software as a Medical Device (SaMD) regulatory strategies and preparing 510k submissions in support of new and existing marketing authorizations for software medical devices 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 execution of Baxter’s regulatory initiatives.

Responsibilities

  • Develop and execute regulatory plans for interoperable software projects including new products and life cycle maintenance.
  • Develop sound regulatory decisions and justifications for changes to software products.
  • Ensure global regulatory strategies for Software as a Medical Device (SaMD) are aligned with business objectives and project scope.
  • Prepare and submit pre-subs, 510(k)s according to FDA guidelines
  • Create and maintain EU STED and Declaration of Conformity Files according to MDR
  • Represent and lead Regulatory Affairs on assigned cross-functional product development teams.
  • Excellent writing skills to develop clear and logical information and conclusions based on design documentation
  • Monitor applicable regulatory requirements; assure compliance with Baxter procedures and external standards
  • Effectively manage complex projects and timelines and communicate with peers within Regulatory Affairs and multiple levels of management.
  • Mentor and coach individuals within Regulatory Affairs 

Qualifications

  • Bachelor’s degree in engineering or other life sciences disciplines
  • 5+ year regulatory experience with working knowledge of software and software development lifecycle (IEC 62304), device interoperability and cybersecurity.
  • Successful preparation and submission of 510(k)s and international documents or registrations
  • Prior software development experience preferred
  • Scientific and sound regulatory knowledge
  • Ability to independently identify and resolve compliance risks and escalate when necessary

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

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037047

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