Associate Director Software, Digital Health/CyberSecurityReq # JR - 014937 Location Deerfield, Illinois, United States Job Category Regulatory Affairs Date posted 02/26/2020
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
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.
Duties and Responsibilities
- Interact across corporation and in industry and regulator settings to influence digital health, software, interoperability and cybersecurity related items.
- Collate global regulatory requirements to help teams develop effective Digital regulatory strategies for delivering optimal timelines for new/modified product approvals.
- Provide independent regulatory guidance to business partners and cross functional project teams, communicate Digital regulatory environment and product submission requirements.
- Partner with Quality to influence and shape the direction of the Quality Management System related to software and interoperability.
- Ensure the application of software and security (i.e., cybersecurity) regulatory standards, guidance documents and industry expectations to existing products, new product strategies and submissions. Interact with and guide other Baxter colleagues who are working on these products.
- A Bachelor’s Degree (BS or BA) in Engineering, Science or equivalent focus is required
- A minimum of 7 years’ experience in FDA 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
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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Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.