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Regulatory Affairs & Quality Assurance Leader, Hainaut
Client: Proselect
Location: Hainaut, Belgium
Job Category: Other
EU work permit required: Yes
Job Reference: 3c43da7acb14
Job Views: 6
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job Description:
Our client is a leading company that specializes in the design, manufacturing, and distribution of high-quality in-vitro diagnostic solutions for healthcare professionals.
We are seeking a highly motivated Regulatory Affairs & Quality Assurance Leader (F/M/X) to join the team.
Responsibilities:
1. Regulatory Affairs:
o Act as a delegate for the Person Responsible for Regulatory Compliance (PRRC) in accordance with EU Regulation 2017/746 (IVDR).
o Manage the transition to compliance with EU Regulation 2017/746 (IVDR) and 21 CFR 820 for existing products, ensuring ongoing compliance.
o Handle CE marking and 510(k) processes for new and existing products, including preparation of technical documentation and liaising with Notified Bodies and the FDA.
o Perform regulatory monitoring and analysis, communicating relevant updates and evaluating impacts on the QMS and product portfolio.
o Train personnel on relevant QMS procedures and regulatory requirements.
o Manage complaints and adverse events, ensuring appropriate investigations and corrective actions.
o Determine and manage product registration requirements in various countries and regions.
o Participate in new product development and validation activities.
o Stay abreast of industry developments and participate in relevant associations and forums.
o Coordinate with other departments to ensure a unified approach to quality assurance and regulatory compliance.
2. Quality Assurance:
o Develop, implement, and maintain the Quality Management System (QMS) in accordance with EU Regulation 2017/746 (IVDR), ISO 13485, ISO 9001, and 21 CFR 820 standards.
o Monitor and report on QMS performance and effectiveness.
o Participate in internal and external audits, manage corrective and preventive actions, and track their implementation.
o Review and approve quality-related documentation.
o Engage in risk management activities and identify areas for QMS improvement.
o Ensure proper documentation, review, approval, communication, and tracking of product and process changes.
o Analyze non-conformities and deviations, develop and implement corrective actions, and monitor their effectiveness.
o Develop and negotiate quality agreements with suppliers, customers, and distributors.
Requirements:
1. Master’s degree in a scientific or engineering field, or equivalent work experience.
2. Minimum of 5 years of experience in quality assurance and regulatory compliance in the medical device or IVD industry, with specific experience in EU Regulation 2017/746 (IVDR), ISO 13485, ISO 9001, and 21 CFR 820.
Competences:
* Proficient in English (speaking, writing, and understanding).
* Strong attention to detail, rigorous, and able to work autonomously.
* Initiative-taking and not afraid of responsibilities.
* Excellent organizational skills, able to prioritize and manage multiple tasks simultaneously.
* Creative, result-oriented, with an analytical and critical mindset.
* Good communication and interpersonal skills, effective in working with cross-functional teams.
Why you should join the team?
Our client offers you a CDI contract made up of some extralegal benefits such as meal vouchers, a 13th month, and paid holidays, hospitalization insurance, etc. You’ll have the opportunity to develop your skills, work with seasoned professionals, and participate in the ongoing growth of a renowned company.
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