Regulatory Affairs & Quality Assurance Leader
Ghislenghien
Solliciteren
Functieomschrijving
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
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Uw uitdaging!
You will play an essential role in the company!As the Quality Assurance Leader, you will ensure compliance with EU Regulation 2017/746 (IVDR), ISO 13485, ISO 9001 standards, and 21 CFR 820, as well as other applicable regulations and guidelines. This role offers the potential for growth and increased responsibilities for the right candidate.Responsibilities:
1. Regulatory Affairs:
- Act as a delegate for the Person Responsible for Regulatory Compliance (PRRC) in accordance with EU Regulation 2017/746 (IVDR).
- Manage the transition to compliance with EU Regulation 2017/746 (IVDR) and 21 CFR 820 for existing products, ensuring ongoing compliance.
- 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.
- Perform regulatory monitoring and analysis, communicating relevant updates and evaluating impacts on the QMS and product portfolio.
- Train personnel on relevant QMS procedures and regulatory requirements.
- Manage complaints and adverse events, ensuring appropriate investigations and corrective actions.
- Determine and manage product registration requirements in various countries and regions.
- Participate in new product development and validation activities.
- Stay abreast of industry developments and participate in relevant associations and forums.
- Coordinate with other departments to ensure a unified approach to quality assurance and regulatory compliance.
2. Quality Assurance:
- 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.
- Monitor and report on QMS performance and effectiveness.
- Participate in internal and external audits, manage corrective and preventive actions, and track their implementation.
- Review and approve quality-related documentation.
- Engage in risk management activities and identify areas for QMS improvement.
- Ensure proper documentation, review, approval, communication, and tracking of product and process changes.
- Analyze non-conformities and deviations, develop and implement corrective actions, and monitor their effectiveness.
- Develop and negotiate quality agreements with suppliers, customers, and distributors.
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Uw talenten
Who are you ?Requirements:- Master’s degree in a scientific or engineering field, or equivalent work experience.
- 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.
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Onze aanbieding
Why you should join the team ?Our client offers you a CDI contract made up some extralegal benefits such as , meal vouchers, 13th month and paid holidays, hospitalization insurance, … You’ll have the opportunity to develop your skills, work with seasoned professionals, and participate in the ongoing growth of a renowned company.Tout candidat intéressé est invité à nous faire parvenir sa candidature via notre bouton « postuler ».
Votre candidature sera traitée avec rapidité et confidentialité.
