Kvalitetsingenjör

Quality assurance and Regulatory affairs manager to MedTech company

Novus Scientific AB, a soft tissue regeneration company based in Uppsala, Sweden is now recruiting a Quality assurance and Regulatory affairs manager with the initial main focus to lead the transition process from MDD to MDR.
At Novus Scientific you will work with highly experienced colleagues within the MedTech industry. This is an excellent opportunity for you to join a great team working with important products classified as class III medical devices. As QA/RA Manager you will have a central role in the company, and this is a once in a lifetime chance for the right candidate to accelerate their career and have fun while doing it!
We are looking for applicants with a good understanding of applicable medical device regulations and standards combined with strong project management skill and a can-do attitude.
Apply today as selection is ongoing and will interview candidates continuously.
We look forward to receiving your application!

JOB DESCRIPTION
As our QA/RA Manager you will have a key role to lead Novus Scientific in the transition process from MDD to MDR. You will have a broad scope of responsibilities related to quality and regulatory compliance. You will be a part of Novus Scientific that today consists of 15 people and you will report directly to the CEO.
Responsibilities include:
– Coordinating projects to implement the MDR 2017/745 or the and supporting relevant department in fulfilling regulatory requirements
– Maintaining Quality management system according to ISO 13485 and FDA’ QSR and all other relevant standards.
– Managing technical documentation for new product development as well as revising already existing technical documentations
– Communicating with responsible regulatory authorities as well as with notified bodies
– Assuring conformity and regulatory compliance of technical documentation throughout product’s life cycle
– Training the organisation on the topic of regulatory affairs
– Staying informed about any changes in relevant legislation etc.
– Producing quality documentation
– Carrying out product quality reviews and performing audits to ensure that all devices comply with regulatory requirements.
– Responsible for conducting internal audits and hosting external audits.

QUALIFICATIONS
The right candidate has a university degree in relevant field and a minimum of 3 years of documented experience in quality assurance and regulatory affairs working with medical devices controlled by ISO 13485 and of MDD/MDR as well as FDA. It is also a plus if you have worked closely with a medical device manufacturing unit.
A perfect command of English language, spoken and written, is an absolute requirement. Other languages are favorable. Experience of working in a smaller, fast paced and dynamic company is seen as an advantage.
To succeed in this role you are reliable, have a high sense of responsibility and you have strong interpersonal skills and a proven record of effectively communicating clearly and accurately.
Furthermore, you are results driven and enjoy working in a fast-paced environment. You have strong project management skills and a structured and organized way of working and can handle multiple tasks independently as well as manage priorities in order to meet projects timelines.
It is important that you have a can-do attitude and the ability to creatively solve problems and to go the extra mile in order to succeed.

ABOUT THE COMPANY
NOVUS SCIENTIFIC AB, a soft tissue regeneration company based in Uppsala, Sweden. The vision is to develop products based on resorbable materials in order to help the body to heal itself. The first product introduced to the market is TIGR® Matrix, the world’s first long-term resorbable surgical mesh. The field of use is in breast reconstruction and abdominal wall reinforcement. All Novus Scientific products are currently classified as class III devices.

In this recruitment Novus Scientific AB is working together with Poolia Life Science.
For the final candidate Poolia will run a background check, you can read more about what this means at: https://www.poolia.se/rekrytering/tillaggstjanster/

Ansök nu
Stad
Uppsala
Publicerad
17 januari
Sista ansökningsdag
31 januari
Omfattning
Tillsvidareanställning
Referensnummer
58303

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