Ra Specialist 3

Intuitive; Barueri; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A leading medical technology company is hiring for a Regulatory Affairs Specialist Level 3. This role involves supporting senior RA specialists in product registration and compliance across LATAM markets. The ideal candidate will have at least 2 years experience in Regulatory Affairs along with a relevant bachelor’s degree. The position requires excellent organizational skills and proficiency in English, and offers a hybrid work model with some flexibility required for time zones.

Qualificações

• Minimum 2+ years of experience in Regulatory Affairs or a related field.
• Strong ability to support and compile regulatory documentation.
• Experience using document management systems.
• Knowledge of international regulatory frameworks like ANVISA.

Responsabilidades

• Support RA Specialists in conducting regulatory assessments.
• Organize documentation for product registration submissions.
• Coordinate with internal stakeholders for timely information.
• Maintain regulatory databases for submission status.

Conhecimentos

Regulatory change assessments

Document compilation for product registration

Organizational skills

Attention to detail

Effective communication

Proficiency in English

Formação académica

Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Chemistry

Ferramentas

Veeva Vault

TrackWise

Descrição da oferta de emprego

Primary Function of Position

The RA Specialist Level 3 plays a key supporting role within the Regulatory Affairs team assisting senior specialists (Levels 4 and 5) in the execution of regulatory activities. This position is responsible for contributing to change assessments gathering and organizing documentation required for product registration submissions and ensuring compliance with applicable regulatory requirements across LATAM markets.

Essential Job Duties

• Support RA Specialists Level 4 and 5 in conducting regulatory change assessments.
• Collect review and organize documentation required for product registration and regulatory submissions.
• Coordinate with internal stakeholders (e.g. R&D Quality Supply Chain) to obtain necessary information and ensure timely submission.
• Maintain regulatory databases and trackers to monitor submission status and document control.
• Assist in preparing regulatory dossiers in accordance with local requirements.
• Ensure compliance with internal procedures and applicable regulatory standards.

Qualifications

• Minimum 24 years of experience in Regulatory Affairs or a related field within the life sciences industry.
• Proven ability to support regulatory change assessments and compile documentation for product registration.
• Strong organizational and time management skills to handle multiple tasks and deadlines.
• Attention to detail and accuracy in document handling and regulatory submissions.
• Effective communication skills to collaborate with cross‑functional teams (e.g. Quality R&D Supply Chain).
• Familiarity with regulatory requirements in LATAM markets.
• Experience using document management systems and regulatory databases.
• Advanced English proficiency is required for effective communication and documentation.

Required Education and Training

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Chemistry or a related discipline.
• Training or coursework in Regulatory Affairs or Quality Assurance is preferred.

Working Conditions

• Hybrid work model with a minimum of 2 days per week at the office.
• Occasional meetings across time zones may require schedule flexibility.

Preferred Skills and Experience

• Experience supporting product registration submissions in multiple LATAM countries.
• Knowledge of international regulatory frameworks (e.g. ANVISA, COFEPRIS, INVIMA).
• Familiarity with regulatory software tools (e.g. Veeva Vault, TrackWise).
• Ability to read and interpret technical product documentation.
• Spanish language skills are a plus, especially for communication with local authorities and affiliates.

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.