Medical Devices Expert 243

ProductLife Group is looking for a Medical Devices Expert to join our dynamic team to contribute to the activities performed in the Hub:

• Medical Device Expert with a focus on Development and a strong Regulatory Affairs interest
• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling.
• Review tasks for, support and mentor Quality and Regulatory Affairs Associates.
• Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
• Contribute to data entry in PLG tools enabling measurements of KPI and metrics for quality and regulatory services supplied by the platform/hub
• Compile, or supervise the compilation of quality set of documents in compliance with national requirements., SOP, WI templates
• Handling Non Conformities on processes and material
• Capability to handle CAPA entirely of part of it (in case specify CAPAs handling skills)
• Support internal and external audits based on ISO 13485 ( even related activities for preparation ) CE marking approval support
• Coordinating activities in order to handle Technical Documentation aspects :
• Technical file support drafting and Design STED handling
• Declaration of conformity (according to MDD and MDR)
• Compliance activities
• Involvement approval processes:
  -Liaise with sponsor head-office and affiliate departments on regulatory issues EU In country       registrations
  -FDA Premarket approval (510K) support
  -MDSAP support preparation.
  -MDR transition support including biological evaluation of Technical File, according to the       series of ISO 10993 .

• MSc/PhD in Life Sciences, Chemistry, Medical Biology, Pharmacy or equivalent in Engineering
•  Min  5 years to 10 years in MD
• Expert experience in Development of Medical Devices (Class I, II & III)
• In depth knowledge & understanding of Medical Device Regulation 2017/745
• Able to define a Regulatory Strategy for a Medical Device
• Expert handling Technical documentation: able to write and review technical documentation for class II & III medical devices.
• ISO 14971 and ISO/TR 24971 Risk management approach and tools for medical devices
• ISO 13485 QMS in Medical Devices – audit preparation and implementation of Quality Management Systems (including ISO 9001)
• Knowledge of specific standards and Regulations: IEC 62304, IEC 82304-1, IEC 62366 , RoHS, REACH, WEEE
• Able to support the transition from MDD to MDR
• Able to support MDSAP, MDR, INMETRO Audits
• FDA inspection support and regulatory pathways