Regulatory Affairs Specialist

hace 3 semanas

Capital Federal Buenos Aires, Argentina Abbott Laboratories A tiempo completo

**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.

**The 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 are 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.

As **Regulatory Affairs Specialist**, you’ll have the chance to perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the local regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. You will be responsible for providing support to all regulatory affairs activities for new and in-line IVD products within the country, ensuring compliance with Abbott standards and applicable regulations.

**What You’ll Do**
- Coordinate, prepare, or review regulatory submissions for new Diagnostics products as well as renewals.
- Product Registration Master File: Compile and maintain regulatory documentation databases or systems.
- 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
- Experience: One (1) year in 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.

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