A3P Biomedical is a Swedish diagnostics company specialized in advanced prostate cancer diagnostics. A3P’s main product, Stockholm3, a blood test for early detection of aggressive prostate cancer, has the potential to radically improve prostate cancer diagnostics. A3P Biomedical’s vision is to significantly reduce the mortality of prostate cancer, one of the world’s most common cancers. We are currently promoting and selling Stockholm3 in Sweden, Norway, Finland, Germany, Switzerland, and Spain and will enter more markets in the near future, with a focus on Europe and the US.
You will be part of our Regulatory and Quality Assurance team consisting of four other people. Two Quality Managers, who will report to you, one Regulatory Affairs Specialist and our Director Regulatory and Quality Assurance.
At A3P Biomedical we are in the middle of a growth journey and no two days are the same. If you like a fast-paced workplace and want to be part of a great team and influence our way forward, this could be the role for you!
- Lead a team of two senior employees. Coach and support them in their assignments and development.
- Ownership of the Quality Management System (QMS). Promote QMS and its principles throughout the organization. Including providing day to day support and leadership and as well as work on continuous improvement of the QMS.
- Training of the organisation in the quality system and related standards.
- Responsible for the non-conformity, CAPA, risk management and change control processes.
- Owner of Change Management board.
- Lead internal audits to identify opportunities for improvement and coordinate external audits when requested.
- Support activities in accordance with the quality and regulatory affairs organisation overall business plan and in alignment with the overall business objectives.
- Operate effectively with the applicable accreditation bodies and regulatory authorities, appropriate administrators, healthcare/caregiver.
- Participate in quality and regulatory discussions with external partners and customers.
- Act as management representative as appointed from top management.
- Quality representative in key product development projects to manage quality activities within the product lifecycle while coordinating activities to appropriate quality personnel.
- Communicate escalation of relevant issues from projects to management as necessary.
- University degree within relevant area or experience from a similar position.
- +5 years’ experience in leading roles within Quality Assurance and Regulatory Compliance.
- Demonstrable knowledge of quality management systems ISO 13485 and IVDD/IVDR/MDD/MDR and IEC62304.
- Medical Device industry experience, preferably in manufacturing and development of software IVD devices.
- Excellent verbal/written communication skills in Swedish and English.
It is a plus if you also have
- Knowledge in FDA 21CFR part 820 and part 11, IEC62304, ISO 15189 and ISO 14971.
Who you are
- You have the ability to work independently and with high energy drive your area of responsibility forward in a structured and results-oriented way.
- You are solution-oriented and always strives for good collaborations.
- You have strong leadership qualities and organizational skills as well as the ability to adapt quickly to changing priorities, assignments, and roles.
At A3P Biomedical you will have the opportunity to work for an entrepreneurial company with global ambitions. Your work will help improve men’s health and quality of life as well as radically improve prostate cancer diagnosis. If you want to learn more about who we are and what we do, please visit our website at: A3P Biomedical
Submit your application in English as soon as possible, no later than Wednesday 14th of December. The recruitment process is ongoing and may be completed before the last application day. We look forward to reviewing your application!