Distro

Regulatory Affairs Analyst – Quality Assurance (Mid-level)

Distro

full-time

Posted on:

Location Type: Hybrid

Location: Barueri • Brazil

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About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory compliancedata analysisquality management systemspharmacovigilancetechnovigilanceregulatory processestechnical dossier preparationincident notificationpost-market surveillancecomplaint management
Soft Skills
analytical abilitydisciplineflexibilitycustomer focus