Regulatory Affairs Specialist

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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.

Baxter is seeking a highly skilled and motivated individual to join ourteamasaPrincipalSpecialistin RegulatoryAffairs. This is anoutstanding opportunity to contribute to the success of aworld-class healthcare company and make ameaningfulimpact on patients' lives.

THISISWHEREyoubuild trust to achieve results.

AsaPrincipalSpecialistinRegulatoryAffairs, you will support the development of business strategies for compliance with registration plans, ensure the obtaining and maintaining productregistrationsand local certifications for imported products for the Business Units, provide regulatory support to the company, and participate in optimising improvement processes.

Our customers trust you and appreciate your knowledge and curiosity when finding solutions to meet their needs.

What you'll be doing:

Serve as a consultant to managers. Lead regulatory activities relating to a specific portfolio of products/projects in a country.
Lead and manage the regulatory affairs activities for the assigned product portfolio
Develop and implement regulatory strategies to ensure adherence to local regulations and laws
Collaborate with cross-functional teams to acquirevital approvals for productregistrationsand maintain existing licenses.
Prepare and submit regulatory submissions to health authorities and provide support during audits and inspections.
Stay updated with the latest regulatoryrequirementsand industry trends to providementorship and ensure flawless execution.
Collaboratecloselywith regional and global regulatory teams to align strategies and exchange practical approaches.
Support the Legal Manufacturer (BHSA) in its fulfilment of its regulatory responsibilities under the MDD and MDR.
Support BHSA and other Baxter legal manufacturers in CE mark related regulatory activities in front of the Notified Bodies and relevant Competent Authorities.

What you'll bring:

Degree in a relevant scientific field
Experienced specialistinRegulatoryaffairs within the medical device or pharmaceutical industry
Proventrackrecord of successfullyimplementing regulatory strategies and acquiring product registrations
Solidunderstanding of regulatoryrequirementsand processes
Excellent communication and interpersonalskills
Experienced using systems such as Trackwise / TCU document control / RIM Vault
Ability to work independently and collaborate effectively in a cross-functional teamenvironment

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#LI-BAXGEN

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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Explore this location ApaTech Limited 360 Centennial Avenue Elstree
Hertfordshire
Hertfordshire
WD6 3TJ
United Kingdom Explore This Location

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Regulatory Affairs Specialist

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