freelance
Medical Device Regulation Quality Associate Reference number: 1453
Last update: 26-06-2020, 12:16
Region: Braine-L'Alleud
Sector: Pharmaceutical
Start: 01 Sep 2020    End: 31 Dec 2020
Job description
Ensure MDR Implementation for the successful re-certification of medical device product portfolio within the boundaries of quality, time and budget. Provide product quality support to execute all activities to obtain CE marking in compliance with MDR.
What you’ll do
  • Support our client's transition planning of medical device product portfolio from MDD to MDR
  • Perform comprehensive review of MDR gap assessment for products
  • Support remediation of MDR compliance gaps identified during assessment
  • Provide Guidance to multifunctional teams to ensure MDR certification requirements are met for medical device product portfolio
  • Provide product quality support to implement revised product labelling, product verification and validation, risk management, clinical evaluation, post market surveillance and support sustaining product activities to achieve MDR compliance
  • Review product documentation for accuracy and compliance to MDR
  • Provide Guidance on maintenance of product Design History Files and Risk Management Files according to Quality System
  • Act as QA Approver for product verification and validation and MDR product Change Controls (CC)
    As member of R&D Europe
  • Comply with our client's Quality and Environmental Health and Safety policy
Profile
  •  Technical skills
    o Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally.
    o Individual must be extremely well organized, and be customer focused with strong interpersonal skills.
    o Ability to work with minimal supervision
    o Compliance knowledge in the areas of product development, MDR, , change control, CAPA
    o R&D minded
  •  Language skills:
    o English is a must, French/Dutch is nice to have
  •  Computer skill:
    o Microsoft office application
    o Knowledge required: Word, Excel, Outlook,
    o Experience in Trackwise is an asset
  • Experience:
    • University degree in Pharmacy, Engineering, chemistry, biochemistry.
    Number of years of experience: 2 to 3 years in Pharmaceutical/medical devices industry per EU and/ or FDA requirements (GLP/GMP/ISO13485 regulation)
    - Knowledge of MDR regulation is a must
    -Experience in Quality Initiatives (processes, systems, improvements) is a must
    -Field of expertise: Analytical method development/validation, laboratory activities or stability studies is an asset
Required Skills
  • Minimum 2 to 3 years in Pharmaceutical/medical devices industry per EU and/ or FDA requirements (GLP/GMP/ISO13485 regulation)
  • Knowledge of MDR regulation
  • Experience in Quality Initiatives (processes, systems, improvements)
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