QA/ra Officer

il y a 2 semaines

Brussels, Belgique RADIOMICS Temps plein

In order to meet our regulatory and quality objectives, we are looking to expand our team with a **QA/RA Officer **.

As Radiomic's **QA/RA Officer **, you will help develop and safeguard quality and regulatory strategies, policies, processes and standards in line with Radiomics' activities by maintaining its certified Quality Management System.

Together with our QA Officer, you will support the different departments of Radiomics in their duties. This includes ensuring the compliance of Radiomics' Software as Medical Device (SaMD) to the company, user and regulatory requirements, both during and after development.

More specifically, you will:

- maintain the Quality Management System and its certificates (ISO 13485, IEC/ISO 27001,.);
- define vision and goals for the QA/RA department
- have PRRC responsibilities such as checking the conformity of devices in accordance with the quality management system, ensure the technical documentation is generated and up to date, and make sure the company complies with post marketing obligations
- ensure all the legal standards are met and review thoroughly
- maintain current knowledge of relevant regulations, including regulations proposed and already in place
- support the company through regulatory intelligence efforts in staying abreast of newly issued regulatory laws, guidance and technical publications
- manage communications and report events to the competent authorities and/or notified bodies
- assess and follow-up risk analysis
- manage internal and external audits programs
- develop strategies to improve the development of software as a medical device
- ensure SaMD compliance during pre and post market phases
- analyse quality assurance data and make recommendations for improvement to management
- develop, implement and monitor corrective/preventive measures
- make documentation of quality assurance and regulatory affairs activities

**What is in it for you?**

In addition to a permanent contract, we offer you:

- the unique opportunity to help shape a high potential start-up active in a leading-edge AI medical field
- the possibility to contribute to the improvement of the way cancer patients are cared for
- a huge and rapid personal growth potential with an integration, training, and mentoring program
- a young, dynamic, and multicultural environment
- empowerment, accountability, and recognition
- an attractive salary package, in line with the position responsibilities and your experience

**Profil**:
You are the talent we are looking for if:

- you hold a degree in Engineering, Medicine, Physical, Biological Sciences or any other sciences-related field;
- you have worked for at least 5 years in a highly regulated environment;
- you know everything about (software as) medical devices and their regulations and requirements (ISO13485, MDR745/2017,...), both in Europe and in the US;
- you are familiar with Quality Management System maintenance and know how to involve your colleagues in the processes;
- you are interested in digital healthcare and are willing to have a strong impact on cancer treatment by helping pharma companies and clinical professionals embrace new biomarkers in their drug development and decision making
- you know how to motivate and lead others to achieve the same goals
- you can express your opinion gently and be assertive when the situation demands it
- you are a team player, but you are also capable of working independently if the situation demands it
- you have incredible organizational skills and can see the big picture
- you have a hands-on, solutions-oriented, and pragmatic mindset
- you are ambitious, fast learner, passionate, curious, and creative
- you know how to synthesize complex issues into simple messages
- you have strong communication skills in English (written and verbal) - French is considered an asset
- you are familiar with Microsoft 365 (including PowerPoint, Excel, Teams,.)

  • Ra/qa Officer

    il y a 3 semaines

    Brussels, Belgique Immunodiagnostics System Ltd Temps plein

    **RA/QA Officer**: **QA/RA - Belgium**: Department: QA/RA Type: Permanent Based: Hybrid **Salary**: Competitive Closing Date: 17/03/2024 Start Date: ? IDS est l'un des principaux fournisseurs en solutions de diagnostic in vitro sur le marché des laboratoires cliniques. Nous développons, fabriquons et commercialisons des immunoessais innovants et des...

  • Ra/qa Officer

    il y a 1 semaine

    Brussels, Belgique Immunodiagnostics System Ltd Temps plein

    **RA/QA Officer**: **QA/RA - Belgium**: IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients. The Liege site was founded as a spin off from the University of Liege in...

  • Deputy Rp

    il y a 2 semaines

    Brussels, Belgique BTG Specialty Pharmaceuticals Temps plein

    Current Opportunity SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines which address rare and life-threatening diseases. Following strategic acquisitions and targeted developments, SERB has succeeded in establishing a consistent drugs portfolio focused on niche specialty pharmaceuticals to ensure...

  • QA Officer

    il y a 2 semaines

    Brussels, Belgique Immunodiagnostics System Ltd Temps plein

    **QA Officer**: **QA/RA - Belgium**: IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients. The Liege site was founded as a spin off from the University of Liege in 1989...

  • Regulatory Affairs and Quality Assurance Coordinator

    Il y a 2 mois

    Brussels, Belgique Oxford Global Resources Temps plein

    **Regulatory Affairs and Quality Assurance Coordinator**: - Location: Brussels, Belgium - Contact: Aurore Munaut - Job type: Contract - Contact phone: +32 10685331 - Industry: Pharmaceutical Reporting to the Head or RA/QA, the Regulatory Affairs (RA) and Quality Assurance (QA) Coordinator is responsible for executing operational administrative RA and QA...

  • QA Officer

    il y a 1 semaine

    Brussels, Belgique HAYS Temps plein

    Liege | QA Officer | FR - EN | CDI **Notre client** ***Notre client est une biotech active dans la province de Liège. Dans le cadre d’une réorganisation interne, le département QA a été remodelée afin d’y ajouter un poste medior. Ils sont donc actuellement à la recherche d’une personne ayant au moins 2 années d’expérience dans une fonction...

  • QA Officer

    il y a 2 semaines

    Brussels, Belgique LOTUS HR Temps plein

    Heb jij een Master afgerond binnen de Life Sciences of Farmacie en wil jij binnen Quality Assurance uiteindelijk graag doorgroeien tot back-up Qualified Person (QP), of heb je dit certificaat al? Lees dan snel verder! Voor een werkgever die toelevert aan de sector Life Sciences (pharma) te regio Brussel, ben ik namelijk op zoek naar een QA Officer. **LOTUS...

  • Quality Assurance

    il y a 1 semaine

    Brussels, Belgique Covartim Temps plein

    **Super-hero working for the compliance of medical devices** - ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746_ mean more than a series of numbers and letters for you? Working on several projects in parallel does not scare you? But, on the contrary, you are looking for a varied job? Knowing that your job can have an impact on people's health gets you...

  • Clinical Affairs Officer

    il y a 1 semaine

    Brussels, Belgique Covartim Temps plein

    **The validator of innovative technologies** You want to make use of your medical expertise? - CIP, CIR, CEP, CER, PMS, PMCF, PSUR_ ring a bell for you? Do you agree that the matter lies in the details or beyond the details? Then you cannot miss this job ad! **Who we are?** COVARTIM is an engineering company located in Brussels. Our mission is to help...

  • Clinical Affairs Officer

    Il y a 2 mois

    Brussels, Belgique Covartim Temps plein

    **De beoordeler van innovatieve technologieën** Wil je je medische expertise inzetten? Zeggen CIP, CIR, CEP, CER, PMS, PMCF, PSUR je iets? Ben je het ermee eens dat het hem in de details zit? Dan mag je deze vacature niet missen! **Wie zijn wij?** COVARTIM is een ingenieursbureau gevestigd in Brussel. Onze missie is om de MedTech-industrie te helpen...

  • Clinical Affairs Officer

    il y a 1 semaine

    Brussels, Belgique Covartim Temps plein

    **De beoordeler van innovatieve technologieën** Wil je je medische expertise inzetten? Zeggen CIP, CIR, CEP, CER, PMS, PMCF, PSUR je iets? Ben je het ermee eens dat het hem in de details zit? Dan mag je deze vacature niet missen! **Wie zijn wij?** COVARTIM is een ingenieursbureau gevestigd in Brussel. Onze missie is om de MedTech-industrie te helpen...

  • Quality Assurance

    il y a 1 semaine

    Brussels, Belgique Covartim Temps plein

    **Superheld die zich inzet voor de conformiteit van medische hulpmiddelen** Betekenen ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746 voor jou meer dan een reeks cijfers en letters? Schrikt het parallel werken aan verschillende projecten je niet af? Maar ben je juist op zoek naar een afwisselende baan? Als je weet dat jouw job een impact kan hebben...

  • QA Officer

    il y a 3 semaines

    Brussels, Belgique Science Talents Temps plein

    **Job description**: Kom jij het QA-team te versterken? Voor onze klant, een bekend voedingsbedrijf, zijn we op zoek naar een QA officer. - Je zal advies geven met betrekking tot voedselregelgeving, certificering of customer compliance. Het faciliteren van naleving van regelgeving om onze organisatie te helpen een uitstekende reputatie te behouden is je...

  • QA Officer

    il y a 1 semaine

    Brussels, Belgique LaCAR MDx Technologies Temps plein

    **LaCAR MDx Technologies SA** **QA Officer** Want to join a growing company? Motivated to learn and take on challenges in the biotech industry? Willing to be part of a company where we help each other and encourage green and social initiatives? As a **QA Officer **you will contribute to the development and the maintenance of the Quality Management...

  • Regulatory Affair Business Unit

    il y a 3 semaines

    Brussels, Belgique Alter Pharma Group Temps plein

    Department | Regulatory Affairs - Full-time- Brussels- Alter Pharma Group NV**ABOUT OUR COMPANY**: **Alter Pharma **is a Belgian group of pharmaceutical companies with headquarters in Anderlecht (Belgium) and offices in Ireland and the United States. Employing in total over 140 employees, the Group distributes a wide range of pharmaceutical products to...

  • Regulatory Affair Business Unit

    Il y a 2 mois

    Brussels, Belgique Alter Pharma Group Temps plein

    Department | Regulatory Affairs - Full-time- Brussels- Alter Pharma Group NV**ABOUT OUR COMPANY**: **Alter Pharma **is a Belgian group of pharmaceutical companies with headquarters in Anderlecht (Belgium) and offices in Ireland and the United States. Employing in total over 140 employees, the Group distributes a wide range of pharmaceutical products to...

  • Regulatory Affair Business Unit

    il y a 4 jours

    Brussels, Belgique Alter Pharma Group Temps plein

    Department | Regulatory Affairs - Full-time- Brussels- Alter Pharma Group NV**ABOUT OUR COMPANY**: **Alter Pharma **is a Belgian group of pharmaceutical companies with headquarters in Anderlecht (Belgium) and offices in Ireland and the United States. Employing in total over 140 employees, the Group distributes a wide range of pharmaceutical products to...

  • Quality Assurance

    il y a 2 semaines

    Brussels, Belgique Covartim Temps plein

    **Een superheld die zich inzet voor de conformiteit van medische hulpmiddelen** Betekenen ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746 voor jou meer dan een reeks cijfers en letters? Schrikt het parallel werken aan verschillende projecten je niet af? Maar ben je juist op zoek naar een afwisselende baan? Als je weet dat jouw job een impact kan...

  • Quality Assurance

    il y a 2 semaines

    Brussels, Belgique Covartim Temps plein

    **A super-hero working for the compliance of medical devices** - ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746_ mean more than a series of numbers and letters for you? Working on several projects in parallel does not scare you? But, on the contrary, you are looking for a varied job? Knowing that your job can have an impact on people's health gets...

  • QA Officer

    il y a 3 jours

    Brussels, Belgique Pharma Chemicals Temps plein

    **QA Officer** Pharma Chemicals est une entreprise pharmaceutique spécialisée dans l'approvisionnement, la division, l'analyse et la distribution de matières premières et de produits pharmaceutiques pour les pharmacies et les hôpitaux. Pour soutenir la croissance actuelle, nous souhaitons élargir notre équipe ! Etes-vous intéressé(e) par...