Regulatory Affairs Specialist

EY; Buenos Aires; Presencial; ARS 700.000 - 1.000.000; Jornada completa

Descripción de la vacante

A global healthcare leader in Buenos Aires is seeking a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance with applicable regulations. Responsibilities include preparing documentation, communicating with regulatory authorities, and reviewing promotional materials. The ideal candidate will have a BS in Biochemistry or Pharmacy and one year of relevant experience. Strong teamwork and organizational skills are essential. Join us for a diverse opportunity to build your career with a commitment to employee diversity.

Formación

• One (1) year experience in a similar position in Regulatory and Quality Assurance areas.
• Knowledge of country regulatory environment.

Responsabilidades

• Coordinate, prepare, or review regulatory submissions for new Diagnostics products.
• Compile and maintain regulatory documentation databases or systems.
• Communicate with regulatory authorities concerning pre‑submission strategies.
• Interpret regulatory rules or rule variations.
• Provide technical review of data for regulatory submissions.
• Review product promotional materials for compliance.
• Determine types of regulatory submissions required.
• Maintain current knowledge of existing and emerging regulations.
• Prepare additional information for regulatory agencies.
• Review clinical protocols for data collection.

Conocimientos

Teamwork

Planning

Organizing

Execution skills

Fluency in English

Educación

BS in Biochemistry or Pharmacy

Herramientas

MS Office

Descripción del empleo

Regulatory Affairs Specialist

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Opportunity

This position is sited in Retiro (Edificio Laminar) in our Diagnostics Division: We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems is often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

What You’ll Do

• Coordinate, prepare, or review regulatory submissions for new Diagnostics products as well as renewals.
• Compile and maintain regulatory documentation databases or systems (Product Registration Master File).
• Communicate with regulatory authorities concerning pre‑submission strategies, potential regulatory pathways, test requirements, or explanation and follow‑up of submissions under review.
• Interpret regulatory rules or rule variations and ensure that they are applied in new registers.
• Provide technical review of data or reports that will be included into regulatory submissions.
• Review product promotional materials, labeling, technical documents, or test methods for compliance with applicable regulations and policies.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.

Required Qualifications

• BS in Biochemistry or Pharmacy.
• One (1) year experience in a similar position in Regulatory and Quality Assurance areas.
• Knowledge of country regulatory environment.
• Proficiency in MS Office.
• Fluency in English.
• Teamwork, strong planning, organizing, and execution skills; ability to proactively manage workload and meet deadlines.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.