QA/RA Manager

UGLK Science is a Swedish med-tech start-up company with a vision of a world where the shortage of donor kidneys available for transplantation is no longer an issue. Our ex-vivo kidney perfusion technology facilitates reconditioning treatment of donor kidneys that with today’s treatments are deemed unsuitable for transplantation. UGLK Science is since mid-2021 in a strategic alliance with a global pharmaceutical company, and is in a pre-commercial development phase. We plan for first clinical evidence during 2022. We are now recruiting a head of Quality Assurance and Regulatory Affairs, QA/RA Manager.
YOUR FUTURE ROLE
If you have previous experience of a role as QA/RA Manager within med-tech and would like to be part from the beginning of an exciting journey in a company with potentially great societal impact – look no further!
In this role, you will be an operative, business-minded leader for Quality Assurance and Regulatory Affairs. As is normal in a start-up, you will have a quite broad scope of responsibilities related to quality assurance, quality control, regulatory affairs, and compliance. You will establish and implement product registration strategies and plans for new markets and existing markets. You will also lead the work of getting product documentation in compliance with Medical Device Regulation (MDR) 2017/745 and The U.S. Food and Drug Administration (FDA) regulatory guidance for Medical Device as well as provide input to the R&D engineering team. This role calls for an open mindset since you’ll be part of a fast-growing high-tech company. You will perform a broad mixture of strategic and day-to- day responsibilities.
Your tasks will include to:
· Lead, develop, and influence the future of the QA & RA strategy, function, and team members in a multicultural environment.
· Be part of our future, developing new innovative products and solutions, adding value for customers, healthcare, and patients.
· Contributing to business strategies with the development and implementation of QA/RA objective and key results (OKRs).
· Overall responsibility for the Quality Management System, risk management system, QA/RA processes, including internal and external audits.
· Registration strategies and driving the execution of registration plans for development, regulatory approval, and optimal market access globally as required.
· Responsibility for the risk management process and the manufacturer's risk management documentation
· Ensuring Quality Assurance Agreements with suppliers are in place.
· Dialogue with authorities, partners and customers in QA/RA related issues
· Ensuring that the company creates and maintains QMS documentation and relevant technical files (MDR and FDA)

YOUR PROFILE
To be successful in this role you probably have:
· In-depth knowledge of the trends within the quality/regulatory and performance improvement space ISO 13485, ISO 14971, IEC 62304, MDR, etc.
· Experience of working with quality and risk management systems and processes within the med-tech industry in a start-up environment
· Experience of working with liquids as medical devices
· A Master of Science or related education, alternatively relevant job experience
· Excellent understanding of registration procedures and requirements as well as product life cycle management from a regulatory affairs perspective. 
· Strong project management skills
· Organized and analytical mindset with a good sense of details while still keeping an eye on the overall goal of the project
· Ability to work to deadlines and solving issues in a pragmatic and proactive way
· Excellent written and verbal communication skills in Swedish and English (Spanish is meriting)
As a person, you are quality-conscious, communicative and, you like to collaborate. In this role, sensitivity, order, and efficiency are also important. Furthermore, you are goal-oriented, can work independently and you enjoy work in an environment where conditions change. As we work for an even gender distribution, we are happy to see female applicants for this position.
WE OFFER
An opportunity to be the first to “add colour to our QA/RA painting”. As being the company’s first QA/RA Manager, we offer you a unique opportunity to design and create frameworks, and systems for the company to thrive in as we begin a new chapter.
This is an opportunity to work in the field of medical technologies, and where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. The position is a full-time position.
We value physical presence, and you’ll have a desk in our office at the research facility Igelösa Life Science, north of Lund, where you can work side-by-side with the rest of the team. However, working-locations are flexible. We offer you 'freedom with responsibility' – get the job done and have fun while doing it, and don’t forget that we are in this together as a team.
We look forward to receiving your application! Applications will be reviewed and interviews scheduled continuously as applications are received.