Regulatory Submissions Officer

仕事内容

About miDIAGNOSTICS

miDiagnostics is using silicon chip technology that will bring miniaturized, lab-quality tests with built-in device connectivity and rapid results direct to the patient and clinician. Combining a nano-fluidic processor on a chip and a compact reader, miDiagnostics can measure virtually any biomarker from an easily accessed sample such as a single drop of blood. The Company is developing an extensive portfolio of tests for screening, diagnosis and monitoring of a wide range of health conditions, including infectious diseases. Spun out of the world-leading R&D and innovation hub in nanoelectronics and digital technologies, imec, and a research collaboration with Johns Hopkins University, the leading US research and medical centre, miDiagnostics’ goal is to enable fast, comprehensive and cost-effective health analysis, regardless of location. Based in Leuven, Belgium, miDiagnostics is a privately-held company created in 2015.

The Job

With the launch of rapid COVID 19 PCR test, we are currently seeking a Regulatory Submissions Officer to join our “Clinical Development and Regulatory Affairs” team. You will be an active part in accomplishing our goals and in our company’s success.

As our Regulatory Submissions Officer, you will manage regulatory submission activities from compilation of product technical file, 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 a submission, manage and track document upload
• Perform detailed review of available outputs to ensure compliance with Regulatory standards and Health Authority guidance.
• Advise 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

Your profile and competencies

• Bachelors’ or Masters’ degree in a scientific discipline or equivalent by experience;
• we welcome young graduates. If you have a few years (1- 3 years) of prior Regulatory Submission experience in the pharmaceutical industry , IVD industry or the medical device industry it’s an asset;
• 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.

The offer

• A job in a fast-growing and ambitious start-up in the medical diagnostics industry.
• miDiagnostics is an international-oriented company with close connections to two world-class research institutions (imec and Johns Hopkins University).
• Opportunity to grow in a new and exciting cutting-edge field in point-of-care diagnostics.
• Our offices are located in Leuven (Belgium). Relocation to Belgium is needed.

Interested? Please apply via our career website https://jobs.midiagnostics.com/