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senior regulatory specialist CMC - Medical Devices

Job Description

Antal International è una multinazionale dell’headhunting con più di 130 uffici in 35 paesi.
Operations Division è un team specializzato in profili con background ingegneristico in ambito produzione, SCM, Research and Development, costruzioni, qualità, design e tecnico-commerciale
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THE COMPANY
Worldwide leading medical devices manufacturer company

THE ROLE

SENIOR REGULATORY SPECIALIST MEDICAL DEVICES

 

The candidate will be responsible for providing post-approval regulatory support for marketed medical device products. The candidate will lead and drive submission activities related to “Quality” sections of the technical documentation and participate in Notified Bodies or Health Authority interactions on “Quality” regulatory documentation issues.

 

KEY ACTIVITIES/RESPONSIBILITIES
 Coordinate global regulatory impact assessment of manufacturing changes in collaboration with Regulatory Product Leads;
 Lead and drive post-approval regulatory strategies for marketed products with input from Regulatory Product Lead as needed.;
 Provide input into regulatory strategy for development products working closely with the Regulatory Product Lead;
 Author appropriate “Quality” sections of the technical documentation based on input from the Legal Manufacturer, Quality, Operations or Research & development;
 Review design related documents as appropriate and participate in the Risk Management Process;
 Provide regulatory support to other Health functions during Regulatory Authority inspections;
 Serve as Regulatory Affairs representative on facility/site Local Change Management Boards.
 

EXPERIENCE

  • Bachelor’s degree in science, engineering, pharmacy or other health related field; advanced degree highly preferred;
  • Knowledge of development and life-cycle management support of medical devices and/or combination products;
  • 10+ years pharmaceutical industry and 8+ relevant regulatory CMC experience with at least 3+ years specific experience in supporting medical devices;
  • Regulatory submission experience with Class I, II and III medical devices in US and Class IIa & IIb in EU and working knowledge of Technical Files.
  • Fluent written and spoken English

 

Location: Milano

Si prega di inviare CV e lettera di motivazione al ruolo a cmereghetti@antal.com

RIFERIMENTO: CMC Regulatory – Medical Devices

 

Le candidature ritenute in linea saranno contattate entro 30 giorni dalla ricezione.
Grazie fin d’ora tutti coloro che vorranno trasmetterci il loro Cv e, in caso di mancata convocazione, considereremo il profilo professionale per eventuali future esigenze
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Contact

Camilla Mereghetti
+39 02 80 60 601
Italy
 
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