CellaVision works to advance laboratory workflow and diagnostic certainty through intelligent microscopy. We are a world leader in digital microscopy and offer a full solution including instruments and reagents. Our products are used in health care services around the globe.
Are you business oriented and want to take the next step in to a leading position? CellaVision in Lund is looking for a QA/RA Manager to lead and develop the Quality Assurance and the Regulatory Affairs team. Now you have the chance to grow in an international environment, with a strong future belief and where employees are the company's most important resource. Does this sound like an exciting challenge? Then you may be the right person for us!
Your responsibilities
As a QA/RA Manager at CellaVision, you will be responsible for leading a team with extensive specialist expertise in Quality Assurance and Regulatory Affairs, where you will act as a cohesive and coaching force.
This is an on-site position and an important part of your work will include leading and developing work methods, specialist competences and processes in the quality and regulatory area. A challenge lies in seizing development opportunities and retaining already established strengths. You will report to VP Quality, Clinical and Regulatory Affairs.
As a QA/RA Manager you will:
- Be the Person Responsible for Regulatory Compliance (PRRC) of the company, as required by IVDR
- Be the Management Representative for the Quality System, as required by ISO 13485
- Have staff, work environment and budget responsibility for the QA/RA functions
- Be responsible for communication with authorities and Notified Bodies regarding registrations, including applications such as 510(k), application for CE mark etc.
- Be responsible for release of products
- Lead, coordinate and distribute work, delegate responsibilities, and establish and maintain necessary procedures in the area of responsibility
- Keep the quality and environmental management systems up-to-date with laws, regulations and applicable standards and to maintain and streamline work methods and processes
- Play a major role during third party audits
What we offer
Inclusive, Innovative Culture: Work in an international, collaborative environment focused on executing big ideas and adding customer value.
- Work-Life Balance: Flexible hours and reduced working hours to help maintain balance.
- Job Security: We offer a collective agreement, including comprehensive insurance, occupational pension, parental leave supplements, and more.
- Health & Wellbeing: We support your health with free access to a gym, wellness allowance, lunch benefits, sponsored running competitions, and discounts on gym memberships.
- Modern Workplace: Enjoy a vibrant, collaborative office environment that encourages teamwork and innovation.
- Team Spirit: Join us for weekly breakfasts and fun team-building activities.
About You
You will bring a positive and constructive attitude to quality work and its role in daily operations. As a leader, it is important that you are driven by the motivation and enthusiasm of your employees to perform at the same time as you are curious about new developments in the quality area. To be successful in the role of QA/RA Manager we believe that you are result-oriented and have a strategic holistic approach as well as an ability to work hands-on. You are pragmatic and solution-oriented and are good at setting clear requirements and following up on them. You have an analytical and structured mind and the ability and courage to make decisions and drive them through. Finally, we believe you have ahigh integrity in your work.
- We believe that you have a university education equivalent to a Master of Science degree or similar.
- You have well-documented experience of regulatory and quality work and experience from people management.
- You have extensive skills and experience within Quality Assurance for Medical Device, and the ability to pragmatically apply your knowledge in your operational work
- You have experience and are able to drive and coach a team in registration of medical devices in EU and MDSAP countries, and preferably also in other countries.
- It is an advantage if you also have experience in environmental regulations and working in an environmental management system.
- You have an advanced level of English and Swedish, written and verbal
- You have a very good communicative ability.
Ready to Join Us?
Apply as soon as possible via our career site.
We will work with continuous selection and interviews, so please send your application as soon as possible. We do not accept applications via email.
Diversity is on our blood
At CellaVision we understand not only the uniqueness of blood cells but also of people. We strongly believe in the power of diversity and recognize it as a driver of innovation. We are committed to building an inclusive culture for all our people.
CellaVision is a non-discriminatory workplace where qualified applicants receive consideration for employment without regard to race, nationality, ethnic or social origin, age, religion, political orientation, sexual orientation, gender identity/expression, family or marital status, pregnancy, disability, or any other basis prohibited by law.
About us
CellaVision® was established in Sweden in 1994 with a vision to simplify, standardize, and digitize the manual analysis of blood cells in hematology laboratories. The company’s long-term success is a result of our commitment to innovation. Our goal is to provide value to patients, customers, and distributors by incorporating smart solutions into everything we do. Our research and development focus on offering superior analytical and diagnostic certainty by creating an ecosystem that combines reagents with hardware and software. Today CellaVision has 250 employees, with global Headquarters in Lund, Sweden.
The company has market support offices in 16 markets and a presence in over 40 countries with reagent development and manufacturing performed in Martillac, France.
For more information visit www.cellavision.com
To know more about the position, please contact recruiting manager Charlotte Oom, via e-mail: [email protected]
We decline all contact regarding services in advertising, consulting or recruitment.
