CV Reviewer

At Global Recruitment, you have a choice. First, look at our various job opportunities. However, Global Recruitment also offers you another option. Do you want to expand or enrich yourself? We're not just looking for colleagues who can delve deeply into their subject. We're also looking for colleagues we call "liaisons" who can combine our diversity with our services. to each other. and enrich our business.

Global Recruitment is the world's leading inspection, verification, testing and certification company. We are also the global benchmark for quality and integrity. This makes us very proud. This is thanks to nearly ⚠,⚠ colleagues worldwide, including more than ⚠,⚠ employees in Belgium alone. Our people give ⚠% every day and span a variety of expertise, industries and cultures. Our employees develop their own path into the company, services and expertise.

We are currently looking for a Resume Examiner at Global Recruitment ⚠ in Antwerp.

Main purpose of the role

The role of the CV Reviewer is to conduct a technical review* of the MDR CV package to check that the data and its contents comply with Global Recruitment ⚠/⚠ EC; MDR Regulation (EU) ⚠/⚠; IVDR Regulation (EU) ⚠/ ⚠; ISO⚠ standard; and through internal Global Recruitment procedures, with subsequent review (and initial approval) by the Senior Resume Reviewer and final approval by the Global Technical Manager General Manager (Competency).

The Resume Reviewer shall:

• Assist the Senior Resume Reviewer and Global Medical Device Technical Manager (Competency) in implementing the processes required for MDR resume review and subsequent approval.
• Act within the scope of NB ⚠ and review MDR resumes against current procedures, practices and standards.
• In particular, the purpose is to ensure that records and data are retained to provide appropriate objective evidence of compliance with regulatory and Global Recruitment requirements.
• Serve as the point of contact in the MDR CV review process between NB ⚠ and Medical Device Investigators, Principal Investigators and Product Evaluators to ensure communications/issues are resolved in a timely manner.
• Ensure the effective collection and provision of necessary documentation, objective evidence and data (regarding work experience, education, training, advice, etc.).

Primary Responsibilities:

Resume Reviewers verify resume set information for compliance with medical device regulations and internal procedures. The resume reviewer will verify that all critical technical information requested (e.g., supporting MD codes, etc.) has been considered and completed before forwarding the resume set for final resume package review and evaluation.

The Resume Reviewer will determine whether the Resume Package demonstrates:

• The Resume Package has been completed in accordance with relevant procedures; including a detailed review of the information provided by the Global Recruitment Auditor/LA/PA.
• Maintain all records of resume packets and data to provide appropriate objective evidence.
• CV takes into account the requirements associated with medical device specific codes.
• The resume must contain all information about relevant and specific standards/normative documents, previous work experience, etc.
• Conduct employee compliance assessments for initial, ongoing and re-approval of resumes (related to NB ⚠ activities):
• Review resume content to ensure compliance with MDR/IVDR/ISO⚠ requirements.
• Review the applied (medical device) code and ensure the level of competency is appropriate for the code.
• Review information submitted for Level ⚠ audits and ⚠-year audits regarding the Auditor and Lead Auditor roles.
• Check the Mirror Review submission information along with the ⚠-year evaluation for the Product Evaluator role.
• Prepare and update formal Excel review sheets for the following roles (to be used in the next phase of the technical review): Auditor/Lead Reviewer/Product Evaluator.
• See updated resume to add code.
• Revision level alignment ensures all documents are at the correct revision.
• Continuously review resumes against relevant authoritative guidance.
• Assist auditors, lead auditors, and product evaluators in understanding resume required information levels.

Required experience:

Several years of experience in a similar position with a European Notification Body or a medical device manufacturer (as a member of their quality and RA team).

Essential Skills:

• Professional experience in the medical device field as an auditor/assessor/regulatory expert for a notified body or medical device manufacturer.
• Detailed knowledge of global medical device regulations and good analytical skills to identify discrepancies or issues.
• You must fully understand relevant medical device regulations, normative documents and guidelines (EU medical device regulations, national legislation, IMDRF, MDCG, CS, etc.).
• Bachelor's degree (or higher) in biomedical science or similar field.
• Good knowledge and speaking skills of English (B⚠), Business English - required.
• Good writing and verbal communication skills - required.
• Ability to organize own workload according to priorities set by Global Technology Manager MD (Competencies) as defined in /KPI: Timely and accurate
• Able to adapt quickly and show flexibility
• Ability to work within a team
• Positive attitude and willingness to learn

Effective Interpersonal Skills:

• Attention to details/information required for processes with a high sense of responsibility
• Good understanding of major MS Office tools (Word, Excel, Outlook).

Working language: English

We look forward to meeting you! Use the Apply button to send us your story and resume, and maybe you'll join us soon. For more information, please email @.