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3cert Limited

1-10

Full-time (temporary)

Malta

**Location:** Malta or Germany

**Type of contract:** Full-time, Permanent

3cert Ltd. is a **_Certification Body_** located in Malta and Germany, having international business relationships.  
Currently, we are one step before becoming a **_Notified Body_** for MDR. Related to the new tasks we are now facing, we are looking for you – A person with experience in healthcare, medical device industry or certification / notification business.

3cert Ltd. is young and dynamic company with the perks of a start-up, the benefits of a SME but without the common downsides of a small and fresh business.

## Tasks

You will **_Head of Notified Body_** in all tasks related to notification. By that also come tasks in business development.

Moreover, you can **_perform conformity assessment activities_** (audits, technical documentation) according to ISO 13485 / EU MDR. Primarily, you will do the **_assessment of technical documentation and audit QMS_** of selected devices/ technlogies in your field of expertise.

## Requirements

We are looking for you, when you are an open-minded and adaptive person with education and job experience in **_healthcare / life sciences_**. You know how to communicate appropriate to all levels within an organization, verbally and in writing.

You must have a successful completion of a **_university or technical college degree_** or equivalent qualification in relevant studies, e. g. medicine, pharmacy, engineering or other relevant sciences. You also need at least **_4 years of experience_** in the field of healthcare products or related activities such as in quality management system, development, quality assurance, regulatory affairs, testing, research or use.

You have knowledge and understanding of relevant legislation, guidance documents, norms, standards (e. g. Regulation EU 2017/745, MDCG documents, ISO 13485, ISO 17021). Therefore, it is a plus, when you have experience working in a notified body / certification body.

When you are fluent in English (B2-C2 CEFR level), we would consider your  
application. Fluency in German or other languages is a plus.

## Benefits

Join us – a young, motivated and international team. We are, what we expect you to be: open-minded and adaptive.  
Apart that we can grant you **_flexible working times and part time home office_**. You will see the world, as **_traveling_** and meeting new people and companies is part of your daily work. For that we can offer you excellent IT-infrastructure. You will receive a good, customary salary with **_capital formation saving payments_**. 

We can offer you a relocation package which includes a defined amount of money for the moving costs incurred (if applicable). Moreover, we offer you our assistance if you have any questions about your new living arrangements. 

We look forward to getting to know  
you!

Bachelor degree completed

Employee

Entry level

Location: Malta or Germany
Type of contract: Full-time, Permanent
3cert Ltd. is a Certification Body located in Malta and Germany, having international business relationships. Currently, we are one step before becoming a Notified Body for MDR. Related to the new tasks we are now facing, we are looking for you – A person with experience in healthcare, medical device industry or certification / notification business.
3cert Ltd. is young and dynamic company with the perks of a start-up, the benefits of a SME but without the common downsides of a small and fresh business.
<h2 id="tasks">Tasks</h2>
You will Head of Notified Body in all tasks related to notification. By that also come tasks in business development.
Moreover, you can perform conformity assessment activities (audits, technical documentation) according to ISO 13485 / EU MDR. Primarily, you will do the assessment of technical documentation and audit QMS of selected devices/ technlogies in your field of expertise.
<h2 id="requirements">Requirements</h2>
We are looking for you, when you are an open-minded and adaptive person with education and job experience in healthcare / life sciences. You know how to communicate appropriate to all levels within an organization, verbally and in writing.
You must have a successful completion of a university or technical college degree or equivalent qualification in relevant studies, e. g. medicine, pharmacy, engineering or other relevant sciences. You also need at least 4 years of experience in the field of healthcare products or related activities such as in quality management system, development, quality assurance, regulatory affairs, testing, research or use.
You have knowledge and understanding of relevant legislation, guidance documents, norms, standards (e. g. Regulation EU 2017/745, MDCG documents, ISO 13485, ISO 17021). Therefore, it is a plus, when you have experience working in a notified body / certification body.
When you are fluent in English (B2-C2 CEFR level), we would consider your application. Fluency in German or other languages is a plus.
<h2 id="benefits">Benefits</h2>
Join us – a young, motivated and international team. We are, what we expect you to be: open-minded and adaptive. Apart that we can grant you flexible working times and part time home office. You will see the world, as traveling and meeting new people and companies is part of your daily work. For that we can offer you excellent IT-infrastructure. You will receive a good, customary salary with capital formation saving payments. 
We can offer you a relocation package which includes a defined amount of money for the moving costs incurred (if applicable). Moreover, we offer you our assistance if you have any questions about your new living arrangements. 
We look forward to getting to know you!

MEDICAL DEVICE EXPERT (PRODUCT REVIEWER and AUDITOR)

3 to 5 years

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