Hybrid Regulatory Affairs Analyst – Quality Assurance (Mid-level)

at Distro

• Job title: Regulatory Affairs Analyst – Quality Assurance (Mid-level)
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Barueri, Brazil

About the role

• Responsible for regulatory affairs and quality assurance for medical products in Brazil and Uruguay. Focus on post-market activities and compliance with legislation.

Responsibilities

• Perform mandatory notifications of incidents and adverse events to ANVISA and manufacturers in accordance with RDC 67/2009.
• Periodically monitor regulatory portals (NOTIVISA / ANVISA / Ministry of Public Health) and track safety/tecnovigilance alerts.
• Act as the point of contact with regulatory authorities, manufacturers, distributors, healthcare professionals and customers regarding adverse events, technical complaints and post-market actions.
• Maintain and update controls for complaints, field actions, stop shipments, thefts and losses.
• Continuously evaluate the safety and performance of marketed medical devices.
• Analyze post‑marketing data and trends, providing input to the Quality System.
• Update regulatory processes arising from post‑market actions, ensuring regulatory compliance and traceability.
• Interface with Marketing, Service and Sales to analyze trends and support decision-making.
• Periodically review the Official Gazette and the ANVISA portal regarding product registrations and publications from competing companies.
• Control protocols and documents submitted to ANVISA.
• Prepare low- and medium-complexity regulatory processes (registration changes requiring scheduled and/or immediate implementation).
• Update control spreadsheets for products registered with ANVISA.
• Update Technical Dossiers for products registered with ANVISA.
• Interface with all company departments, distributors, service providers and suppliers.
• Skills:
• Candidate must possess, at minimum (but not limited to) the following skills: analytical ability, discipline, flexibility, and customer focus.
• Competencies:
• Candidate must possess, at minimum (but not limited to) the following competencies:
• • Knowledge of key ANVISA legislation related to the business.
• • Knowledge of Quality Management Systems, Pharmacovigilance or Technovigilance.

Requirements

• Education:
• • Bachelor's degree in Pharmacy, Biomedicine, Biology or related fields.
• Experience:
• • Minimum of 3 years' experience in Regulatory Affairs, Quality or Technovigilance (preferably in the medical devices/healthcare segment).
• Training:
• • Microsoft Office package (Word, Excel, PowerPoint).
• • Desirable: training related to regulations RDC 665:2022, RDC 67:2009 or RDC 551:2021.

Benefits

• 20% - Travel to the warehouse