Manager, Regulatory Affairs

☞ Baxter International Inc.

Aussicht: 185

Update Tag: 16-11-2025

Ort: Braine-l’Alleud Walloon Brabant

Kategorie: Recht / Verträge

Industrie: Medical Equipment Manufacturing

Position: Associate

Jobtyp: Full-time

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Jobinhalt

Req # JR - 068035 Location Braine-l’Alleud, Wallonia, Belgium Job Category Regulatory Affairs Date posted 05/23/2022

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.

Summary

Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries.

Essential Duties And Responsibilities
  • Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
  • Represent or lead the RA function on assigned cross-functional project teams
  • Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
  • Establish appropriate communication within RA and other functions primarily at project level
  • Perform gap analysis and propose solutions
  • Develop and document sound regulatory decisions and justifications
  • Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
  • May provide direct supervision of individuals
  • May review promotional material or SOP’s for compliance with local and global regulations
Qualifications
  • Sound basis of Regulatory knowledge
  • Scientific 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
  • EU regulatory knowledge
  • Device experience a plus
Education And Experience

Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects. Higher degree/PhD will be an advantage.

Reasonable Accommodations

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

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our

068035
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Frist: 31-12-2025

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