RA Specialist 3
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 :
Required Skills and Experience
- 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
- Bachelors 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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As pioneer and leading company in the field of robotic-assi ... View more
