Associate Director, Regulatory Affairs - Software & Cybersecurity (Open to Remote)Req # JR - 054252 Location Deerfield, Illinois, United States (Remote) Additional locations Tennessee (remote); South Dakota (remote); South Carolina (remote); Rhode Island (remote); Pennsylvania (remote); Oregon (remote); Oklahoma (remote); Ohio (remote); North Dakota (remote); North Carolina (remote); New Mexico (remote); New Jersey (remote); New Hampshire (remote); Nevada (remote); Nebraska (remote); Montana (remote); Missouri (remote); Mississippi (remote); Minnesota (remote); Michigan (remote); Massachusetts (remote); Maryland (remote); Maine (remote); Louisiana (remote); Kentucky (remote); Kansas (remote); Iowa (remote); Indiana (remote); Illinois (remote); Idaho (remote); Georgia (remote); Florida (remote); Delaware (remote); Connecticut (remote); California (remote); Arkansas (remote); Arizona (remote); Alabama (remote); New York, NY (remote); Washington, D.C. (remote); Wyoming (remote); Wisconsin (remote); West Virginia (remote); Washington (remote); Virginia (remote); Vermont (remote); Utah (remote); Texas (remote) 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.
In partnership with the Digital Health and Product Security teams, lead the strategic direction and operational aspects of regulatory compliance focusing on Baxter’s medical device products with software and/or interoperability with other devices or external networks as well as digital health products. Collaborate with internal and external thought leaders and stakeholders to influence policy regarding software and digital health products and processes and ensure Baxter has a strong voice in the ecosystem.
Essential Duties and Responsibilities:
Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms
Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Guide and influence technical groups in areas of product development, labeling and promotion
Participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc)
Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions
Implement policies to ensure ongoing compliance of regulatory requirements
Develop and implement regulatory strategy aligned with business strategy
Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance
Responsible for negotiating and decision making with regulators and stakeholders with complex and high-risk projects
Provide direct supervision of individuals including mentoring, performance management and staffing decisions
Represent Baxter externally at appropriate industry associations
May act as primary contact with regulatory authorities including the planning and leadership of meetings
May participate in management of budgets
Bachelor’s Degree (BS or BA) in Engineering, Science or equivalent focus is required
A minimum of 7 years’ experience in a regulated industry
Software related regulatory experience is required (e.g., IEC62304, FDA Software/Cybersecurity Guidance Documents); global exposure/experience a plus
Strong technical knowledge of medical software design controls and healthcare IT applications
Excellent written and oral communication, technical writing and editing skills
Strong leadership, interpersonal and influencing skills
Ability to work independently with minimal supervision
Ability to collaborate with cross-functional partners/teams
Strong conflict management and resolution skills; catalyst for positive, collaborative change
Ability to drive pragmatic processes in highly evolving situations
This position can be located remotely within the US, except for Colorado.
If you are based at our Deerfield, IL or Largo, FL facilities your employment is conditional upon being fully vaccinated for 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.
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