Regulatory submission officer

12/10/21

Location

Leuven, Belgium

Function type

Diagnostics

Vacancy

WHAT IS OFFERED

  • Take the lead in managing the regulatory submission activities of challenging projects.

  • An interesting full-time job in a fast-growing organization driven by innovation and science.

  • You will join an open-minded, creative & supportive team that will challenge you to become the best version of yourself.

  • We strive to create a dynamic working environment where you can top yourself and contribute to the success of the company.

  • We will offer you a competitive salary with extra legal benefits.

  • You will not only be supported by the Clinical Development team of our trusted client but also by MindCapture.

 

ABOUT THE COMPANY

The company is developing an extensive portfolio for screening, diagnosis and monitoring of a wide range of health conditions, including infectious diseases.

The Leuven-based company is a spin-out of Imec, the world-leading R&D and innovation hub in nanoelectronics and digital technologies.

As a world-renowned research center, Imec believes in the contribution of technology to a better future. Locally, they put that vision into practice by supporting companies and governments in their sustainable innovation.

JOB DESCRIPTION

  • With the launch of the rapid COVID 19 PCR test, we are currently seeking a Regulatory Submission Officer to join our “Clinical Development and Regulatory Affairs” team.

  • You will be an active part of accomplishing our goals and in our company’s success.

  • As our Regulatory Submission Officer, you will manage regulatory submission activities from a compilation of product technical files, submission to agencies and through the approval process, ensuring that files are prepared to the highest quality standard and in a timely efficient manner.

  • Your responsibilities will be: Prepare, review, and submit product technical file applications to EU and international regulatory agencies.

  • Work closely with R&D and other functional area experts to compile documents needed for submission, manage and track document upload.

  • Perform detailed review of available outputs to ensure compliance with Regulatory standards and Health

  • Authority guidance.

  • Advice on changing regulations and compliance requirements.

  • Track submissions and ensure timely filing of documents.

  • Communicate appropriately with Notified Body to assure timely review process and follow-up on product changes.

  • Be our spokesperson at audit

REQUIRED COMPETENCES & SKILLS

  • Masters’ degree or PhD in a scientific discipline.

  • At least a few years (3 – 5 years) of prior Regulatory Submission experience in the IVD industry or the medical device industry.

  • Critical thinking to identify the alternative solutions by analysis of strengths and weaknesses.

  • Excellent oral and written English skills.

  • Hands-on experience preparing, reviewing, and submitting regulatory documentation.

  • Good communication and presentation skills are a must.

  • Excellent organization skills and efficient time management.

  • Team player attitude.

  • You feel comfortable in a start-up environment and you can easily switch from one task to another.

  • You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues.

  • Our offices are located in Leuven (Belgium). Relocation to Belgium is needed. It is essential that you hold entitlement to work and live in Belgium.

Job application