Sr Spec Regulatory Affairs México

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.

Main Objective

Support the development of business strategies for compliance with registration plans, ensure the obtaining and maintenance of product registrations and local certifications for imported products for the Business Units, provide regulatory support to the company and participate in the optimization of the improvement processes.

Main Activities

• Foster a culture of compliance and ethical business practices in the organization.

• Promote the implementation of the ethics and compliance program and prevent, detect and correct violations of the law, Baxter policies and code of conduct.

• Support the plan for preparing product registrations and local certificates, provide regulatory support to ensure compliance with the local registry plan and ensure that the required product registrations and local certificates are obtained according to the strategic business plan of the Business Units mainly in Brazil, and some other countries in LatAM.

• Support the LATAM regulatory affairs team in obtaining legal documents such as Free Sales Certificates, FDA and ISO, FSC, CFGs from the legacy Hillrom manufacturing plants globally.

• Provide regulatory support to the local and corporate exchange control system.

• Coordinate the Commercial Release for the legacy Hillrom products.

• Keep updated the importations licenses for Mexico.

• Review and approved the promotion and advertising material for legacy Hillrom Products.

• Coordination and support for the Inmetro and B-GMP audits at the manufacturing sites.

• Coordination of the legacy Hillrom products NOM certificates.

Education

Chemical, Pharmaceutical, Biomedical engineering or related

Experience

• Engineer expert in radio frequency, Inmetro, NOMs for equipment

• Telecommunications EXPERT in medical devices.

• 5 to 7 yearsexperience QA and RAMedical devices, equipment & Radio frequency for LATAM countries

Knowledge

Expert knowledge on:

• LatAm regulations and local Certification processes.

• Quality Auditor Skills

• Lean SixSigma – Black Belt

• Legal Compliance knowledge

• NOMs

• Inmetro certification

• Pharmaceutical or related

Competences

• Critical thinking and problem solving

• Communication

• Business knowledge

• Collaboration and teamwork

• Customer focus

• Create effective teams

• Make timely decisions

• Manufacturing management

Attributes

• Work ethics

• Good judgement

• Courage and conviction

• Sense of accomplishment

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 [email protected] and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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