MEDICAL DEVICE EXPERT (PRODUCT REVIEWER and AUDITOR)

Location: Malta, Germany and Hybrid (partly Home Office)

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 support the Certification and Recognition Manager 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 / MDR. Primarily, you will do the assessment of technical documentation of selected product groups 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 745/2017, MEDDEV 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!