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Regulatory Affairs & Quality Assurance Leader (F/M/X)
Client:
Proselect
Location:
[Location not provided]
Job Category:
Other
EU work permit required:
Yes
Job Reference:
3c43da7acb14
Job Views:
4
Posted:
15.02.2025
Expiry Date:
01.04.2025
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.
o Handle CE marking and 510(k) processes for new and existing products.
o Perform regulatory monitoring and analysis, communicating relevant updates.
o Train personnel on relevant QMS procedures and regulatory requirements.
o Manage complaints and adverse events.
o Determine and manage product registration requirements in various countries.
o Participate in new product development and validation activities.
o Stay abreast of industry developments and participate in relevant associations.
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).
o Monitor and report on QMS performance and effectiveness.
o Participate in internal and external audits.
o Review and approve quality-related documentation.
o Engage in risk management activities.
o Ensure proper documentation and tracking of product and process changes.
o Analyze non-conformities and deviations.
o Develop and negotiate quality agreements with suppliers, customers, and distributors.
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.
Competences:
* Proficient in English (speaking, writing, and understanding).
* Strong attention to detail, rigorous, and able to work autonomously.
* Excellent organizational skills.
* Good communication and interpersonal skills.
Why you should join the team:
Our client offers a CDI contract with benefits such as meal vouchers, a 13th month, paid holidays, hospitalization insurance, etc. You’ll have the opportunity to develop your skills and work with seasoned professionals.
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Votre candidature sera traitée avec rapidité et confidentialité.
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