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,.)

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