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CV Reviewer

SGS GROUP BELGIUM in ANTWERPEN
time Online sinds 6 juli 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.

CV Reviewer

SGS GROUP BELGIUM in ANTWERPEN
time Online sinds 4 juni 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.

Chapter Lead Testing Operational Planning & Competencies

YPTO in
time Online sinds 20 juni 2024 - Vaste jobs

The Chapter Lead will play a crucial role in balancing technical expertise with people management.This position involves providing technical guidance, fostering personal and professional development, and ensuring collaboration and alignment within and across teams.The Chapter Lead will work closely with business and IT stakeholders to deliver high-quality products that support business goals and enhance customer experience.
 

Key Responsibilities:

Technical Leadership:

  • Provide expert technical guidance and support to Chapter members in a specific domain (e.g., software development, quality assurance etc).
  • Ensure best practices and high standards are maintained within the Chapter.
  • Stay current with industry trends and technologies to provide relevant advice and direction.

People Management:

  • Focus on the personal and professional development of team members through mentoring, career development, and performance reviews.
  • Foster a supportive and collaborative team environment.
  • Organize optimal workforce planning to meet the needs of various Squads.

Facilitating Collaboration:

  • Facilitate knowledge sharing and collaboration within the Chapter.
  • Work with key business customers, stakeholders, and external partners to identify and address IT needs.
  • Interact with Project Managers, Product Owners, Architecture, Solution Design, Services Delivery, and Support teams to ensure quality product development.

Bridging Squads and Chapters:

  • Maintain coherence and alignment across different Squads, ensuring consistent technical and quality standards.
  • Ensure effective communication and coordination between Squads and Chapters.

Recruitment and Staffing:

  • Participate in recruitment and staffing decisions to ensure the right skills are available within the Chapter.
  • Assess the span of control and adjust the Chapter structure as needed to maintain manageability.

Delivery:

  • Ensure end-to-end IT ownership for projects within the business area portfolio.
  • Engage with Project Managers to create, plan, track, and execute overall project plans.
  • Support the creation of business cases and contribute to project steering committees with clear roles and responsibilities.

Application Management:

  • Oversee application lifecycle management for all applications in the portfolio.
  • Advise on risk management, ensuring effective detection, reporting, and mitigation.
  • Support portfolio management and optimize capacity planning.

Financials:

  • Create and manage departmental budget proposals aligned with business strategy and priorities.
  • Hold financial accountability, including estimation, forecasting, and reporting on OPEX and CAPEX budget actuals.
  • Identify and mitigate financial risks.

Chapter Lead Testing Real-Time Operations

YPTO in
time Online sinds 20 juni 2024 - Zelfstandige activiteit

The Chapter Lead will play a crucial role in balancing technical expertise with people management.This position involves providing technical guidance, fostering personal and professional development, and ensuring collaboration and alignment within and across teams.The Chapter Lead will work closely with business and IT stakeholders to deliver high-quality products that support business goals and enhance customer experience.
 

Key Responsibilities:

Technical Leadership:

  • Provide expert technical guidance and support to Chapter members in a specific domain (e.g., software development, quality assurance etc).
  • Ensure best practices and high standards are maintained within the Chapter.
  • Stay current with industry trends and technologies to provide relevant advice and direction.

People Management:

  • Focus on the personal and professional development of team members through mentoring, career development, and performance reviews.
  • Foster a supportive and collaborative team environment.
  • Organize optimal workforce planning to meet the needs of various Squads.

Facilitating Collaboration:

  • Facilitate knowledge sharing and collaboration within the Chapter.
  • Work with key business customers, stakeholders, and external partners to identify and address IT needs.
  • Interact with Project Managers, Product Owners, Architecture, Solution Design, Services Delivery, and Support teams to ensure quality product development.

Bridging Squads and Chapters:

  • Maintain coherence and alignment across different Squads, ensuring consistent technical and quality standards.
  • Ensure effective communication and coordination between Squads and Chapters.

Recruitment and Staffing:

  • Participate in recruitment and staffing decisions to ensure the right skills are available within the Chapter.
  • Assess the span of control and adjust the Chapter structure as needed to maintain manageability.

Delivery:

  • Ensure end-to-end IT ownership for projects within the business area portfolio.
  • Engage with Project Managers to create, plan, track, and execute overall project plans.
  • Support the creation of business cases and contribute to project steering committees with clear roles and responsibilities.

Application Management:

  • Oversee application lifecycle management for all applications in the portfolio.
  • Advise on risk management, ensuring effective detection, reporting, and mitigation.
  • Support portfolio management and optimize capacity planning.

Financials:

  • Create and manage departmental budget proposals aligned with business strategy and priorities.
  • Hold financial accountability, including estimation, forecasting, and reporting on OPEX and CAPEX budget actuals.
  • Identify and mitigate financial risks.

Internship Financial Analyst

JANSSEN PHA - BEE1 STAGIAIRES in BEERSE
time Online sinds 29 mei 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:

Internship Financial Analyst

JANSSEN PHA - BEE1 STAGIAIRES in BEERSE
time Online sinds 29 mei 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 Pharmaceutica NV 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, more

than one internship will be offered to support the financial activities to support the development of new medicines

and/or vaccines.

Key responsibilities of the internships can include:

- Activities to support the financial close activities: processing journal entries, supporting internal and

external audits,

- Consolidation of back-up documentation for R&D expenses to determine allowability of our costs under

certain grant programs (US Government, European Union,¿)

- Controlling activities: preparation of budget vs.actuals overviews and management reporting on

compounds and departmental spending

- Documenting and analyzing transactions hitting into our SAP accounting system

- Ad Hoc related projects (headcount reporting optimisation, foundations project planning,¿)

Bedrijfsprofiel:

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