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PQE

Contact Details:

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Contact: HR

Description:

The resource shall support Compliance projects in Medical Device area. The resource shall also bring new expertise in quality management and regulatory affairs for Medical Device and contribute to the growth of the Medical Device team and to enhance PQE services in Medical Device area.
JOB FUNCTIONS
Support projects for Medical Device EU and extra EU registration
Support Compliance and Quality Management System projects for Medical Device Companies
Perform audits in Medical Device area

Requirements:

Please send your CV in English ONLY
Degree in Technical discipline
1-3 years in Quality Assurance and/or Regulatory Affairs, in Consultancy or Medical Device industryEnglish language proficiency
Willingness to travel up to 75%
Knowledge of:
Medical Device requirements (ISO 13485, MDD 93/42, 21 CFR part 820, new MDR 2017/745-746 …)
EU and Extra EU MD registration processes
510 (k) and PMA process
Risk Management for Medical Devices

Location:

Center, Sharon, North

Job type:

Full-time

Position Code:

JB-00029
 
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