Regulatory Lead

hace 1 semana

Madrid, Madrid, España BAXTER A tiempo completo

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.

Your Role at Baxter:

We have a wonderful opportunity for a Regulatory Affairs Associate at our office in Madrid.

You will be responsible for managing national regulatory approvals of medicinal products and establishing appropriate contact with the Spanish Regulatory Authorities.

You will ensure that regulatory compliance is maintained for our products/services and will act according to the country policies and practices to reduce Baxter's exposure to regulatory, quality and liability risks.


If you are passionate about regulatory affairs and looking for a place where you choose to work with talented and dynamic people whose primary focus is to save and sustain lives and your work values focus on speed, simplicity, courage and collaboration.

Then we would love to hear from you.

What are your responsibilities?

  • Support the Regulatory Affairs department with all general tasks
  • Review and translate IFUs and labeling of medical devices
  • Maintenance, updates and creation of medical devices in the AEMPS database
  • Maintenance, updates and creation of medical devices in our systems
  • Labelling and Manual translations for medical devices
  • Medical Devices AdProm
  • Maintenance of drugs licenses: variations, labeling & AdProm
  • Review promotional material and manage safety information material
  • Support the CQA department with general tasks as: Field Action implementation, product releases, verification of product compliance and general aspects of quality system compliance

We are presently seeking people who have:

  • Bachelor ́s degree in life sciences required. (Biology, Pharmacy)
  • Experience working in the Department of Registration in the area of health products (experience with pharmaceutical drugs is also highly valued)
  • An eye for details and the ability to work under pressure
  • European and national knowledge of medicinal and health product regulations
  • Fluency in English and Spanish

Why do you want to work at Baxter?

  • Competitive total compensation package
  • Professional development opportunities
  • High importance placed on work life balance (Family Responsible Certificate EFR)
  • Flexible benefits (childcare vouchers, employee discounts, etc.)

Equal Employment Opportunity


Baxter is an equal opportunity employer and is therefore firmly committed towards making employment opportunities available to all qualified applicants without regard to gender, race, age, disability, colour, nationality, ethnic or national origin, marital status, sexual orientation, responsibility for dependents, religion or trade union membership.


Reasonable Accommodations

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 Recruitment Fraud Notice.

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