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CV Reviewer

SGS GROUP BELGIUM in ANTWERPEN
time Online sinds 4 mei 2024 - Vaste jobs

Main Purpose of Role

The role of the CV Reviewer is to perform a technical review* of the MDR CV packs to verify data and their content for compliance required by the MDD 93/42 EC; Regulation MDR (EU) 2017/745; Regulation IVDR (EU) 2017/746; ISO13485 Criteria; and by internal SGS procedures for the subsequent review (and preliminary approval) by the Senior CV Reviewer and the final approval by Global Technical Manager MD (Competence).

The following is expected of the CV reviewer:

  • To assist the Senior CV Reviewer and the Global Medical Device Technical Manager (Competence) to implement the necessary process intended for MDR CV reviews and following approvals.
  • To act within NB 1639 and review MDR CVs in compliance with current procedures, practices and criteria.In particular, to ensure that records and data are maintained to demonstrate appropriate objective evidence of compliance with the Regulatory and SGS requirements.
  • To serve as point of contact as part of the MDR CV review's process between the NB 1639 and the Medical Device Auditors, Lead Auditors and Product Assessors ensuring that communications/queries are resolved in a timely fashion.
  • To ensure that the required documents, objective evidence and data (concerning workplace experience, education, training, consultancy, etc.) are efficiently collected and presented.

Key Accountabilities:

The CV Reviewer verifies that CV set information is in compliance with the medical device regulations and internal procedures.The CV Reviewer verifies that all main requested technical information (e.g.to support MD codes, etc.) has been addressed and closed out before transferring the CV set for a final CV pack review and assessment.

The CV Reviewer establishes whether the CV pack demonstrates:

  • That the CV pack has been completed in accordance with relevant procedures; including a verification of the information provided by SGS auditor/LA/PA in detail.
  • That all records of the CV pack and data are maintained to demonstrate appropriate objective evidence.
  • That the CV has addressed the requirements related to the medical devices' specific codes.
  • That the CV has the full information about relevant and specific standards/normative documents, previous professional experience, etc.
  • To perform conformity assessment of personnel (related to NB 1639 activities) for initial, on-going and re-approval CV assessment:
    • Review CV content to ensure compliance with MDR/IVDR/ISO13485 requirements
    • Review (medical device) codes applied and ensure that the competence level is appropriate for the code
    • Review the submitted information re Level 1 Audit and 3 Years' review for Auditor and Lead Auditor roles
    • Review the submitted information regarding Mirror Review and also for 3 Years' review for Product Assessor role.
    • Compile and update Formal Excel review form for the following roles (for the next stage of the technical review) for Auditor/Lead Auditor/Product Assessor
    • Review of updated CVs to add codes
    • Alignment of Revision level to ensure all documents are at the correct revision
    • Ongoing review of CVs in line with the Competent Authorities guidelines
    • Assist Auditors, Lead Auditors and Product Assesso.

Senior Origination and Tender Officer (2)

PARKWIND NV in LEUVEN
time Online sinds 7 mei 2024 - Vaste jobs
  • Identifying potential new markets by conducting thorough market analyses taking into consideration different influences: political, financial, legal, technical, environmental,…;
  • Building business models in Excel to evaluate opportunities through scenario analysis;
  • Screen markets and opportunities
  • Build and maintain an industry network
  • Assisting in the preparation of business cases and recommendations for the management team;
  • Gathering the necessary input from different internal departments (Finance, Legal, Engineering,…) and external partners to prepare tenders and business cases;
  • Building and maintaining a close collaboration with the Project Teams and internal stakeholders;
  • Initiating contact with potential partners.

  • Managing Parkwind's responses to targeted calls for tenders, in an efficient and autonomous manner and in accordance with Parkwind's strategy and processes
  • Coordinating, preparing and compiling bid submission documents in relation to tendering/bidding activities;
  • Coordinating bid requirements, collating, and compiling the required information;
  • Leading a multi-disciplinary team of internal and external experts throughout the tendering process; soliciting input from and ensuring alignment among internal stakeholders
  • Ensuring completeness of the bid and timely bid submission.
  • Preparing the relevant internal documents for the management and/or board;
  • Working in close collaboration with and under the oversight of the Tender lead to ensure tender structure and terms are consistent with corporate strategy and mandate;
  • Representing Parkwind in interactions and negotiations with counterparties and at industry events with outstanding competence, professionalism, and integrity.