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CV Reviewer

STEPSTONE in ANTWERPEN
time Online sinds 3 april 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.

IT Project Manager

EDITX in
time Online sinds 13 maart 2024 - Vaste jobs

You like being involved in the technology and business part of your product?

Then becoming our IT Project Manager (ITPM) might be your thing !

 

As IT Project Manager (ITPM) you will work within the TSP department, which stands for Trains, Stations & Planning.

You will be designated to the Business Area Stations, which is the IT partner of the NMBS-SNCB Directorate B-Stations.This Business Area implements and maintains the tools to manage NMBS- SNCB Real Estate portfolio such as the Stations, concessions, parking’s, lands and buildings.This from the early study phase of a new tools, over their implementation to enhancements on existing applications.

In your role as ITPM you will have a strong focus on the BUILD activities, next to that you:

  • Will act as the primary contact point towards the Business Product Manager.
  • Have the end-2-end accountability for the IT-side of the assigned projects/applications/components.
  • Collaborate with a wide range of people to identify and define business needs, understand the solution context and develop the vision, roadmap and features required to meet these needs.
  • Steer the projects in your portfolio, manage/structure the project backlog, coordinate delivery and sprints scope, review and possibly co-write user stories.
  • Lead the scrum team in agile mode.
  • Have full cost ownership of the assigned project/application portfolio.
  • Report on regular basis on status, proceedings of the project on several levels, including Steerco.

Teamlead ICAM

EDITX in
time Online sinds 16 februari 2024 - Vaste jobs

Within the CISO department, the Identity, Credential & Access Management (ICAM) team exists alongside the Cyber Centre of Excellence and GRC Office teams.The ICAM team, together with external partners, manages the critical identity and access management architecture that ensures that our travelers and our staff and partners can access the applications they need, day in and day out, in an efficient and secure manner.This team also oversees the identity and access management processes.

 

Key Activities
 

People management
 

  • Ensure clear governance, including roles and responsibilities, accountability and delegation of tasks within their team.
  • Coach and steers the team where necessary and guides individual team members in their personal development together with the CISO and the HR business partner.
  • Recruit and hire new ICAM team members with the right qualifications, knowledge and skills.
  • Is the first escalation point for the team member of the ICAM team.

Financial and capacity management

  • Determine yearly budget (OPEX and CAPEX) together with the experts and the CISO and closely follow up on it through KPI’s, metrics and reporting.
  • Manage the necessary capacity planning for OPEX activities and projects.

Service management

  • Create, maintain and improve a capability and service overview/ catalogue owned by the ICAM team
  • Maintain all aspect of the lifecycle management of these capabilities and services:
    • Design, formalize, implement KPI’s and metrics for each capability and underlying service.
    • Identify and escalate operational, financial and quality risks.
    • Create new services or improve existing services in order to meet a customer or business need, always driving by creating added value.
    • Guard and coordinate the technical quality and operational efficiency and effectiveness of the daily operations.
    • Monitor external suppliers required for providing the services.
    • Report to (internal) customer (KPI reporting, planning, capacity, quality)

Project management

  • Translate new services into concrete projects together with the program manager and lead expert to launch the necessary project demand and initiation requests
  • Act as the project sponsor for the lead experts within the team (who are the project owners) and ensure all internal steps are followed while timely delivering the necessary Requests for Initiation and Request for Proposals to the market.

Internship Financial Analyst

RANDSTAD INHOUSE SERVICES in BEERSE
time Online sinds 16 april 2024 - Tijdelijke jobs
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of

people everywhere.Career opportunities within Johnson & Johnson companies may provide you with an ideal

setting to build your leadership experience, express your passion, and touch the world.

Janssen Research & Development aims to transform patients' lives by discovering and developing innovative

solutions to address the most important medical needs of our time.Within the Janssen R&D Finance

organization,

Global Development group together with around¿ 9000¿ internal and external colleagues from across the globe, we

manage clinical sites¿ and the execution of clinical trials, lead the operational delivery of clinical R&D trials and

programs, transform data into information to build knowledge, deliver the medical affairs portfolio & pre-approval

access and implement a great variety of¿ clinical operations processes and systems.

Key responsibilities of the role include:

- Supporting Affiliate funding process including Quarter close Journal Entry posting

- Supporting Flex process with reconciliation and Journal Entry posting

- Time compliance reports ¿ sharing the reports with the finance team.

- Travel&Entertainment expense reporting for Global Development organization

- Headcount management on ad-hoc basis for Global Development

- Creation of new cost centers, Non-Development projects codes and overall master data transactions

- Assisting reporting activities.

Bedrijfsprofiel:

VOOR JANSSEN PHARMACEUTICA, ONDERDEEL VAN JOHNSON EN JOHNSON CAMPUS BEERSE, ZIJN WIJ OP ZOEK NAAR:

Application Owner Ticket Vending Machines

EDITX in
time Online sinds 27 februari 2024 - Vaste jobs

You take end-to-end responsibility for managing existing applications and implementing new solutions in a specific business area to optimize performance, stability, consistency, lifecycle and usability of the assigned application portfolio.

Your responsibilities

  • Ensure that the application serves its intended purpose and delivers value to the business.The role of an application owner is to guide the software development lifecycle to performance gains that align with the business vision
  • The application must meet the standards deemed acceptable by all stakeholders, customers, and partners.The application owner guide the development teams to find an optimal trade-off between: Functionality; Performance; Dependability; Cost; User satisfaction
  • Provide appropriate operational, management and technical controls that help mitigate and manage security risks facing software apps, network infrastructure, end users, and the business
  • Follow the service level agreement (SLA) metrics to ensure there is a timely response/resolution to incidents related to the application
  • Support the business by prioritizing product backlog and helping deliver business outcomes
  • Identify areas of improvement and develop a long-term quality improvement program that encompasses the technology and business aspects of the software application

Main activities

  • Advise the client on the improvement, optimization and innovation of business processes, information flows and applications
  • Support the customer in validating and prioritizing their needs and resolves possible bottlenecks proposing alternative solutions
  • Convert validated and prioritized needs/issues into standard features or functional specifications for a custom solution into a business analysis document
  • Check consistency with existing enterprise and solution architecture and seeks advice from enterprise, system and solution architects
  • Report on the progress of analyses, processes and the proposed solution and ensures the formal validation of this solution in terms of architecture and functionality
  • Act as a subject matter expert for business process owners and IT staff regarding the application
  • Translate the functional analysis into a configuration, taking into account the specific requirements of the module(s) used
  • Prepare technical documentation and related configuration documentation
  • Provide training materials
  • Develop test scenarios