The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Medical Device, Quality/Risk Management, Submission & Registration
4 Year Degree
Are you looking for a career that matters?
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.
Regulatory Affairs Specialist is responsible for the development and implementation of global regulatory strategies, obtaining and maintaining marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Additionally, providing on-market regulatory support for currently registered global products and expansion of products into new markets.
Global Regulatory Lead for a portfolio of Class II / Class I medical devices marketed worldwide.
Represent global regulatory affairs and act as a liaison for local country RA on cross-functional project teams
Ensure regulatory activities are in alignment with business prioritization
Track of status and progress of regulatory documentation and deliverables required to support regulatory submissions
Manage product lifecycle activities including regulatory impact assessments of product changes and product labeling development
Maintain regulatory files in a format consistent with regulatory requirements and internal procedures
Support local country RA on product Geographic expansion initiatives and product lifecycle activities
Provide guidance and regulatory strategies to project teams supporting new product development
Respond to regulatory authority inquires under strict deadlines
Assist with maintenance activities for regulatory systems and procedures
May act as primary contact with US FDA and/or EU agencies for standard activities related to product development or compliance
Scientific knowledge and ability to discuss technical matters with cross-functional teams.
Good written and verbal communication and presentation skills
Good technical system skills (e.g. word processing, spreadsheets, databases, online research, Document Management System)
Manage multiple projects, activities, priorities and deadlines
Ability to identify compliance and / or project risks and escalate when necessary
Required Bachelor’s degree or country equivalent in a scientific discipline with a minimum of 5 years regulatory or equivalent experience within a healthcare company, contract manufacturer, or similar organization. Ideal candidate will also possess working knowledge of medical device registration regulations in the United States. EU and international experience / knowledge in medical device regulations will be an advantage
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.
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.
Internal Number: JR - 022638
Baxter touches the lives of millions of people around the world every day. Our products and therapies can be found throughout hospitals and clinics – from the ER to the OR, from the pharmacy to the ICU – as well as advancing patients’ care in their homes.
For more than 85-years, we have been at the critical intersection of saving and sustaining lives. And now, we are determined and uniquely positioned to realize our greatest opportunity to transform global healthcare for years to come.