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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.

Senior Quality Assurance Officer

SERB NV in ELSENE
time Online sinds 3 juli 2024 - Vaste jobs

QUALITY

  • Deputy Qualified Person for batch certification according to the Directive 2001/83/EC on medicinal products for human use and the guidelines on Good Manufacturing Practices (GMP) (Volume 4).
  • Deputy RP for Good Distribution Practices (GDP) according to the Directive 2001/83/EC on medicinal products for human use and the guidelines of 5 November 2013 on GDP for medicinal products for human use.
  • Review, compilation and release of batch records for administrative (GDP) release or batch certification (GMP), as appropriate.
  • Completion of register of released batches (and samples).
  • Quality oversight of contracted out manufacturing operations.
  • Assist in the management of the distribution including import and export of medicines.
  • Review and approval of transfer and validations of manufacturing and testing operations.
  • Lead the drafting/approval of product specifications.
  • Assist in the preparation of the quality management review at group level.
  • Proactively participate as a senior quality team member in the company's QMS processes, including but not limited to deviation/investigation management, corrective and preventative actions, change control and complaints management.
  • Ensure compliance with marketing authorisations / CE mark (regulatory dossier).
  • Assist in the management/coordination of all activities related to a batch recall
  • Proactively participate in the management of artwork and marketing/promotional materials.
  • Assist in the management of stability studies and Product Quality Review.
  • Ensure the compliant implementation of serialization.
  • Audits & Inspections:
    • Participate in the preparation and risk assessments for the internal and external audit schedules.
    • Plan and lead external audits.
    • Participate in inspections by competent authorities as a subject matter expert.
    • Participate in self-inspections / internal audits.

Other

  • Assist in local aspects of Regulatory Affairs
  • Assist the Medical and Vigilance (Pharmaco and Materiovigilance) department to ensure compliance at SERB SA.
  • Assist in the management of medical / scientific information requests.
  • Assist in the management of advertising, samples, compliance in relation to the RP function for Belgium, Luxembourg and the Netherlands.
  • Assist in the management of prices and refunds for Belgium, Luxembourg and the Netherlands.
  • Monitors the regulations in force and their evolution.
  • Assist for budget management.

Team management

  • This role does not have reporting staff, but is expected to work within the matrix of the local (SERB SA) and wider (SERB Pharmaceuticals) quality teams as a senior member.This will include providing support, training and mentoring to the more junior members of the team as required for team development and efficient and compliant performance of the team.

Senior Quality Assurance Officer

SERB NV in ELSENE
time Online sinds 3 juli 2024 - Vaste jobs

QUALITY

  • Deputy Qualified Person for batch certification according to the Directive 2001/83/EC on medicinal products for human use and the guidelines on Good Manufacturing Practices (GMP) (Volume 4).
  • Deputy RP for Good Distribution Practices (GDP) according to the Directive 2001/83/EC on medicinal products for human use and the guidelines of 5 November 2013 on GDP for medicinal products for human use.
  • Review, compilation and release of batch records for administrative (GDP) release or batch certification (GMP), as appropriate.
  • Completion of register of released batches (and samples).
  • Quality oversight of contracted out manufacturing operations.
  • Assist in the management of the distribution including import and export of medicines.
  • Review and approval of transfer and validations of manufacturing and testing operations.
  • Lead the drafting/approval of product specifications.
  • Assist in the preparation of the quality management review at group level.
  • Proactively participate as a senior quality team member in the company's QMS processes, including but not limited to deviation/investigation management, corrective and preventative actions, change control and complaints management.
  • Ensure compliance with marketing authorisations / CE mark (regulatory dossier).
  • Assist in the management/coordination of all activities related to a batch recall
  • Proactively participate in the management of artwork and marketing/promotional materials.
  • Assist in the management of stability studies and Product Quality Review.
  • Ensure the compliant implementation of serialization.
  • Audits & Inspections:
    • Participate in the preparation and risk assessments for the internal and external audit schedules.
    • Plan and lead external audits.
    • Participate in inspections by competent authorities as a subject matter expert.
    • Participate in self-inspections / internal audits.

Other

  • Assist in local aspects of Regulatory Affairs
  • Assist the Medical and Vigilance (Pharmaco and Materiovigilance) department to ensure compliance at SERB SA.
  • Assist in the management of medical / scientific information requests.
  • Assist in the management of advertising, samples, compliance in relation to the RP function for Belgium, Luxembourg and the Netherlands.
  • Assist in the management of prices and refunds for Belgium, Luxembourg and the Netherlands.
  • Monitors the regulations in force and their evolution.
  • Assist for budget management.

Team management

  • This role does not have reporting staff, but is expected to work within the matrix of the local (SERB SA) and wider (SERB Pharmaceuticals) quality teams as a senior member.This will include providing support, training and mentoring to the more junior members of the team as required for team development and efficient and compliant performance of the team.

Customer Service OTC - work-life balance - Brussels area

PAGE PERSONNEL in BRUSSEL
time Online sinds 8 mei 2024 - Vaste jobs

In this Customer Service role with a focus on Order to Cash (OTC), you are involved in the entire process from order processing to payment and following up after payment.

Client Details

Imagine being part of a thriving international medical company located in Flemish Brabant, near Brussels.This company is not only fast-growing but also a top employer, recognized for its excellent work environment, onboarding, and people management.

Here, you have the opportunity to be involved in exciting projects and collaborate with talented professionals from diverse cultures.The company promotes a healthy work-life balance, offering flexible work options and focusing on employee well-being.

The team atmosphere is vibrant and supportive, with an emphasis on collaboration and celebrating successes together.This is more than just a workplace; it's a community of innovation, creativity, and growth.

In conclusion, this is the premier choice for those seeking an engaging career in the dynamic field of Medical & Pharma.

Description

  • Order Processing: customer orders, check product availability, scheduling delivery, and entering order details into the system.

  • Customer Communication: main contact for customer inquiries regarding orders, deliveries, invoices, and payments.

  • Interdepartmental Collaboration: Working with other teams to ensure seamless order-to-cash processes.

  • Invoicing and Payment Management: Preparing and sending invoices, monitoring payments, and following up on overdue accounts.

  • Process Improvement: Contributing to efforts to enhance efficiency and customer satisfaction through process enhancements.