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12 jobs voor Safety Manager gevonden in Leuven (3000)

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Clinical regulatory affairs specialist

SYNERGIE LEUVEN in LEUVEN
time Online sinds 19 juli 2024 - Vaste jobs

What will your main tasks be?

  • Prepare and update clinical evaluation plans and reports (CERs) for Class III medical devices;
  • Liaise with internal and external stakeholders to ensure timely completion of CERs;
  • Prepare and update PMS plans, periodic safety update reports (PSURs), post-market clinical follow-up (PMCF) plans and reports, and summaries of safety and clinical performance (SSCPs) for Class III medical devices;
  • Conduct clinical literature and vigilance database searches;
  • Conduct PMCF studies (e.g.surveys) and collaborate with the Product Management Department or support consultants conducting such studies;
  • Implement scientifically and statistically sound methods into study plans and data analyses;
  • Participate in the design, management and reporting of clinical investigations as required;
  • Liaise with Sales, Marketing and QA Departments to ensure PMS activities are conducted under regulatory supervision;
  • Ensure relevant CE marking documents, including product technical files, are complete and up to date;
  • Perform vigilance activities as required.

You will also have to ensure that the organisation consistently meets legal obligations, focusing on:

  • Compliance with the Medical Device Regulation (MDR) for Class III medical devices;
  • Clinical evaluation requirements under the MDR;
  • Post-market surveillance (PMS) requirements under the MDR.

Bedrijfsprofiel:

Join a leading innovator in the dental industry as a Clinical Regulatory Affairs Specialist.Do you want to advance your career with a globally recognized company known for its high-quality products, and already have some experience in clinical research and medical writing?Then this role is perfect for you!

Electrical Offshore Substation Package Manager

PARKWIND NV in LEUVEN
time Online sinds 6 juni 2024 - Vaste jobs

General responsibilities:

  • Management of the function
  • Set up the budget for the design, construction and installation of an offshore substation and final responsibility of the budget
  • Make, implement and maintain a milestone plan for the initiation and completion of all the works related to the offshore substation

Tasks and special responsibilities:

  • Create the technical Employer Requirements and check, assess and approve the engineering and design of the offshore substation
  • Initiate the Tender process and close contracts for supply and installation of the offshore high voltage station
  • In general, ensure that relevant HSE requirements are satisfied within the activities, whether these requirements are defined by legislation, contract or project plans
  • Manage the team which is in charge of design, construction and installation of the topside.
  • Set-up the planning for the substation works in line with the overall planning, follow up that planning and take necessary actions if deviations occur
  • Proactively ensure that nothing has fallen between chairs in the function's interface and take ownership of any such work
  • Ensure that state of the art competences are engaged as required
  • Check, assess and approve (internal) the engineering and design of the Electrical infrastructure of the offshore substation
  • Carefully and diligently check that the supplied equipment, components, tools, services and documentation are in compliance with the employer requirements and Contractor's specification through focused reviews, inspections, witnessing etc
  • Proactively manage the Supply and Installation Contract of the substation, to ensure the works are executed safely, delivered promptly, on schedule and on budget and in a good quality all in accordance to the Project Execution Plan
  • Ensure that the necessary recommendations on the choice of technical solutions and preferred suppliers are generated and approved by the overall Electrical Package and EPCI Manager in a timely matter
  • Obtain the approval of the Electrical Package Manager of any resolution of any commercial, contractual or legal matter or issue under the substation Supply and Installation Contract
  • Proactively identify and take ownership of risks and mitigate consequences of these
  • Execute actions in a timely manner
  • Maintain a good and strong relationship between the EPCI contractor and the different Stakeholders.

Flexibility (in both directions) will be a large part of your function.Primarily you will be based in our offices in Leuven.You will have the opportunity to perform offshore visits and occasionally you will have to travel, both in Europe and overseas.

Electrical Offshore Substation Package Manager

PARKWIND NV in LEUVEN
time Online sinds 6 juni 2024 - Vaste jobs

General responsibilities:

  • Management of the function
  • Set up the budget for the design, construction and installation of an offshore substation and final responsibility of the budget
  • Make, implement and maintain a milestone plan for the initiation and completion of all the works related to the offshore substation

Tasks and special responsibilities:

  • Create the technical Employer Requirements and check, assess and approve the engineering and design of the offshore substation
  • Initiate the Tender process and close contracts for supply and installation of the offshore high voltage station
  • In general, ensure that relevant HSE requirements are satisfied within the activities, whether these requirements are defined by legislation, contract or project plans
  • Manage the team which is in charge of design, construction and installation of the topside.
  • Set-up the planning for the substation works in line with the overall planning, follow up that planning and take necessary actions if deviations occur
  • Proactively ensure that nothing has fallen between chairs in the function's interface and take ownership of any such work
  • Ensure that state of the art competences are engaged as required
  • Check, assess and approve (internal) the engineering and design of the Electrical infrastructure of the offshore substation
  • Carefully and diligently check that the supplied equipment, components, tools, services and documentation are in compliance with the employer requirements and Contractor's specification through focused reviews, inspections, witnessing etc
  • Proactively manage the Supply and Installation Contract of the substation, to ensure the works are executed safely, delivered promptly, on schedule and on budget and in a good quality all in accordance to the Project Execution Plan
  • Ensure that the necessary recommendations on the choice of technical solutions and preferred suppliers are generated and approved by the overall Electrical Package and EPCI Manager in a timely matter
  • Obtain the approval of the Electrical Package Manager of any resolution of any commercial, contractual or legal matter or issue under the substation Supply and Installation Contract
  • Proactively identify and take ownership of risks and mitigate consequences of these
  • Execute actions in a timely manner
  • Maintain a good and strong relationship between the EPCI contractor and the different Stakeholders.

Flexibility (in both directions) will be a large part of your function.Primarily you will be based in our offices in Leuven.You will have the opportunity to perform offshore visits and occasionally you will have to travel, both in Europe and overseas.

Electrical Package Engineer

PARKWIND NV in LEUVEN
time Online sinds 6 juni 2024 - Vaste jobs

As Electrical Package Engineer, you will:

  • Provide technical High Voltage support to the electrical package team
  • Assist in the design process, supplier selection process andfabrication and installation phase of the offshore and onshore substation and HV/MV cables
  • Identify and check the technical and contractual interfaces between substation contracts, cable supply contracts and installation contracts
  • Ensure that relevant HSE requirements are satisfied for the different contracts
  • Assist in the technical part of the Employer Requirements process
  • Report to the Electrical Package Manager.

Furthermore, during the construction phases of our projects you will follow up fabrication and construction works in the factories and the pre-assembly and construction sites.

Tasks and Responsibilities:

  • Predesign of basic electrical HV infrastructure and SLD for operating an offshore windfarm
  • Define and calculate the major components of which the electrical infrastructure of a windfarm is composed of: HV and MV cable sections, HV transformers, shunt reactors,…
  • Participate in the design review with contractors of the proposed overall electrical infrastructure for an offshore wind farm
  • Follow up the different tenders issued for the Electrical Infrastructure
  • Review the contractor's assumptions and documents to assure a feasible design as well as a design that meets the Parkwind requirements on availability and maintainability
  • Check the proposed electrical design in respect to the grid requirements of the TSO, the Parkwind Employer Requirements and interface descriptions
  • Assist in discussions with TSO/Contractor regarding grid compliance requirements, the design of the reactive power compensation and implementation
  • During production phase check quality assurance and product specification of cables produced
  • Monitoring of production schedules
  • Witnessing of the factory acceptance tests (FAT)
  • Overall inspection of the quality plan of the manufacturer and the production records (internal checks, deviations and routine tests)
  • Build up knowledge on the applicable IEC standards and the critical items during FAT of cables
  • During the onshore and offshore installation phase of the wind farm follow up and check the necessary quality assurance and control related to the offshore substation commissioning and cable installations
  • Interface coordination and management between the different scopes and parties such as the Supply and Installation Contractor of the export cable and infield cables and OHVS contractor
  • Evaluation of transport plans and provisions
  • Quality and HSE control on onshore cable installation and jointing procedures and workmanship
  • Interface coordination TSO – Contractor on HV connection, protection settings, information exchange and reactive power compensation
  • Evaluation of commissioning and test plans

Flexibility (in both directions) will be a large part of your function.Primarily you will be based in our offices in Leuven.You will have the opportunity to perform offshore visits and occasionally you will have to travel, both in Europe and overseas.

Electrical Package Engineer

PARKWIND NV in LEUVEN
time Online sinds 6 juni 2024 - Vaste jobs

As Electrical Package Engineer, you will:

  • Provide technical High Voltage support to the electrical package team
  • Assist in the design process, supplier selection process andfabrication and installation phase of the offshore and onshore substation and HV/MV cables
  • Identify and check the technical and contractual interfaces between substation contracts, cable supply contracts and installation contracts
  • Ensure that relevant HSE requirements are satisfied for the different contracts
  • Assist in the technical part of the Employer Requirements process
  • Report to the Electrical Package Manager.

Furthermore, during the construction phases of our projects you will follow up fabrication and construction works in the factories and the pre-assembly and construction sites.

Tasks and Responsibilities:

  • Predesign of basic electrical HV infrastructure and SLD for operating an offshore windfarm
  • Define and calculate the major components of which the electrical infrastructure of a windfarm is composed of: HV and MV cable sections, HV transformers, shunt reactors,…
  • Participate in the design review with contractors of the proposed overall electrical infrastructure for an offshore wind farm
  • Follow up the different tenders issued for the Electrical Infrastructure
  • Review the contractor's assumptions and documents to assure a feasible design as well as a design that meets the Parkwind requirements on availability and maintainability
  • Check the proposed electrical design in respect to the grid requirements of the TSO, the Parkwind Employer Requirements and interface descriptions
  • Assist in discussions with TSO/Contractor regarding grid compliance requirements, the design of the reactive power compensation and implementation
  • During production phase check quality assurance and product specification of cables produced
  • Monitoring of production schedules
  • Witnessing of the factory acceptance tests (FAT)
  • Overall inspection of the quality plan of the manufacturer and the production records (internal checks, deviations and routine tests)
  • Build up knowledge on the applicable IEC standards and the critical items during FAT of cables
  • During the onshore and offshore installation phase of the wind farm follow up and check the necessary quality assurance and control related to the offshore substation commissioning and cable installations
  • Interface coordination and management between the different scopes and parties such as the Supply and Installation Contractor of the export cable and infield cables and OHVS contractor
  • Evaluation of transport plans and provisions
  • Quality and HSE control on onshore cable installation and jointing procedures and workmanship
  • Interface coordination TSO – Contractor on HV connection, protection settings, information exchange and reactive power compensation
  • Evaluation of commissioning and test plans

Flexibility (in both directions) will be a large part of your function.Primarily you will be based in our offices in Leuven.You will have the opportunity to perform offshore visits and occasionally you will have to travel, both in Europe and overseas.