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Quality Assurance/Regulatory Affairs Manager

Permanent contract
Watermael-Boitsfort
Salary: Not specified
Starting date: August 31, 2022
Occasional remote
Experience: > 5 years
Education: Master's Degree

COVARTIM
COVARTIM

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The position

Job description

As part of the Quality Assurance/Regulatory Affairs (QA/RA) team, the QA/RA Manager will provide support for the development of innovative medical devices. (S)he will manage QA/RA activities such as, but not limited to:

  • Quality Management System implementation;
  • Standards watch and gap analysis;
  • Audits (internal/external);
  • Review and preparation of documentation packages for notified bodies, FDA, competent authorities.

Preferred experience

Hard skills:

  • Good understanding of Medical Devices and IVD regulatory environment (directives, regulations);
  • Good knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards;
  • Fluent in English and French/Dutch.

Soft skills:

  • Quality and customer-service oriented;
  • Focused on details;
  • Team-player with strong communication skills;
  • Ability to work cross-projects and excellent organizational skills;
  • Autonomous and eager to learn;
  • Strong interest in Lifesciences, Technology and Innovation.

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