Revvity
Revvity
Revvity — зерттеулер, диагностика және клиникалық тестілеуге арналған шешімдер әзірлейтін денсаулық сақтау және өмір туралы ғылымдар саласындағы компания. Оның өнімдері мен қызметтері геномдық талдауды, дәрі-дәрмек әзірлеуді, дербестендірілген медицинаны, жасушалық және гендік терапияны, клиникалық диагностиканы және зертханаларды автоматтандыруды қолдайды. Revvity академиялық ортадағы, фармацевтика және биотехнология компанияларындағы, клиникалық зертханалардағы және денсаулық сақтау саласындағы клиенттермен жұмыс істеп, ғылыми зерттеулерді ілгерілетуге және диагностикалық әрі терапиялық инновацияларды нарыққа шығаруға көмектеседі.

Regulatory Affairs Quality Specialist - Brazil Remote

Support Revvity’s Brazil and LATAM healthcare quality operations through regulatory affairs, ANVISA compliance, QMS management, audits, CAPAs, regulatory files, and technical vigilance documentation.

Сипаттама

  • Draft registration dossiers and risk revalidations for managerial review and approval
  • Maintain the Brazil RMP and Smart Sheets in line with manager guidance
  • Support ANVISA Good Distribution and Storage Practices management with Responsible Technicians and CoRTs at the 3PL site
  • Open and track Non-Conformities
  • Monitor CAPAs with relevant departments
  • Manage LATAM QMS documentation
  • Support distributor qualification and requalification audits
  • Support service-provider qualification and requalification
  • Provide LATAM field-action and technical-vigilance documentation with company RTs and CoRTs
  • Organize regulatory files according to manager guidance
  • Draft and maintain regulatory affairs and ANVISA GDP/GSP procedures within the LATAM QMS
  • Follow established processes and seek managerial guidance when necessary
  • Complete other occasional activities agreed with the manager
  • Follow Revvity policies and applicable LATAM QMS procedures
  • Complete other occasional activities agreed with the manager

Талаптар

  • The posting does not specify experience, education, certifications, language requirements, or other qualifications.

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