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Quality & Regulatory Engineer - Medtech - LLN

Company

Our client is MedTech company located in Louvain-la-Neuve. This dynamic company aims at developing and commercializing next generation active implantable medical devices and biosensors for the treatment of neurological disorders using a wide range of technologies such as electronics, embedded software and signal processing, biomedical engineering, mechanical engineering, material sciences and optics.

Role

Your role

Part of a small team, you and your team are involved in the update and the improvement of the Quality System based on the ISO 13485 (see job purpose). You are also involved on regulatory topics and you ensure a good communication with R&D team in order to develop products respecting regulatory and quality requirements.

Your responsibilities

  • You are in support of the update and improvement of the Quality Management System.
  • You are in support of the different steps and aspects of the Quality Management: Risk Management System, CAPA Management, Internal and External Audit, Traceability, Quality Control, Design Control, CE marking, etc.
  • You contribute actively, on proposing the regulatory strategy in the framework of R&D pre-market programs, to ensure conformity to regulations in force such as MDR.
  • You support the R&D team in planning and executing the necessary regulatory activities with the aim of obtaining CE certification.
  • You are in support of the revision of technical files and in the creation of such documentation in order to assess compliance.

Profile

The successful candidate will have the following skills, knowledge, experience and qualities:

BACKGROUND

• University or High School Degree in Electronics Engineering, Biomedical Engineering, Applied Mathematics Engineering or similar applicable to the job description

• Min. 2 years of relevant experience in medical devices QA/RA functions

HARD SKILLS

• Good understanding of medical devices regulatory environment (MDD 93/42, MDR) & Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards

• Good verbal and written communications skills in English and French (speaking work environment)

SOFT SKILLS

• Passionate about Biomedical Engineering, medical devices, technology and innovation

• Thorough, hands on approach

• Showing attention to details, with the ability to cope with the complexities and tensions of a rapidly developing programme

• Able and willing to work and evolve in a start-up atmosphere

• Organisational, flexibility, adaptability and responsiveness skills

Offer

Our client offers a friendly, dynamic and ever evolving start-up atmosphere and team. You would have the chance to get involved in the company evolution and in the full chain of development, from specifications to clinical investigations and market and, ultimately, help improve people’s life.

Our client offers a full-time open-ended contract and good salary package, flexible advantages and trainings.

Publication date

02.04.2021

Contact person

Gaëlle Minet

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