Regulatory Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil BAXTER Tempo inteiro

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


Responsible for the local implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of medical devices products.

Serves as a consultant to managers. Manage regulatory activities relating to specific portfolio of products/projects.

What you'll be doing

  • Initiate and develop complex regulatory project plans
  • Identify & prioritize key areas of regulatory risk
  • Monitor applicable regulatory requirements
  • Create and maintain regulatory files in a format consistent with requirements
  • Provide regulatory advice to project teams.
  • Respond to complex questions from regulatory authorities within strict timelines
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Maintain and update existing regulatory authorizations
  • Manage regulatory activities relating to specific portfolio of products/projects
  • Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
  • Prepare SOPs to reflect specific local requirements.
  • Lead or represent Regulatory Affairs in project teams
  • Provide guidance and coaching for areas of responsibility to lower level team member

What you'll bring
Bachelor's degree in a Pharmacy or equivalent

Fluent English is mandatory, Spanish, at least intermediate

Knowledge of local regulations
Project management skills
Manage multiple projects and deadlines
Ability to multitask and prioritize
Interpersonal and communication skills
Strong negotiation skills
Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Ability to work effectively in multinational/multicultural environment
Ability to identify compliance risks and escalate when necessary

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.

092586

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