Quality & Regulatory Affairs Manager – Medical Devices

Company Description: Monidor is an Oulu-based MedTech company developing technology for hospital-at-home care and virtual wards. Our mission is to enable safe, hospital-level care beyond hospital walls by connecting the patient, the care team and real-time information into one effective care pathway.Our strategic focus is Monidor Care Case, a ready-to-deploy solution for remote patient monitoring. Its technological foundation is Monidor Vitals, a CE-marked MDR Class IIb medical device approved for both hospital and home healthcare use. The solution brings together medical devices, continuous and spot monitoring of vital signs, remote alarms, video communication and integrations with hospital information systems. We are now looking for a Quality & Regulatory Affairs Manager to take ownership of Monidor’s quality and regulatory activities and help us develop the next generation of remote patient monitoring.At Monidor, quality is not simply a support function. It is essential for patient safety, successful product development and international growth. Your RoleYou will take responsibility for an established ISO 13485 quality management system through a planned handover from our current Quality Manager. You will not be starting from scratch: Monidor has a mature quality system, certified medical devices and extensive experience in regulated product development. Quality and regulatory affairs will form the core of your role. Depending on your experience and interests, the position can also include responsibility for development projects, product-related initiatives or defined workstreams within larger projects. Your responsibilities will include:Maintaining and continuously improving Monidor’s ISO 13485 quality management systemEnsuring compliance with the EU Medical Device Regulation and other applicable requirementsCoordinating internal and external auditsWorking with the notified body, authorities, suppliers and external expertsManaging CAPAs, nonconformities, change control and supplier qualitySupporting risk management and maintaining technical documentationCoordinating post-market surveillance, feedback and vigilance activitiesBringing practical quality and regulatory guidance into product development and software releasesSupporting third-party medical device integrations and the development of smart algorithms and AI-assisted reportingTraining and supporting the team in quality-related mattersLeading or participating in cross-functional development projects The exact scope and initial level of responsibility will be adapted to the selected person’s experience. For an experienced QARA professional, the role offers broad ownership from the beginning. For a candidate with a strong quality and project background, we can offer a structured path towards wider QARA responsibility. What we are looking forYou may already be an experienced QARA professional or a strong growth candidate ready to take the next step. In either case, you are comfortable taking ownership, applying sound judgement and turning requirements into practical action. We expect you to have:A relevant BSc or MSc degree in engineering, technology, life sciences or another suitable fieldPractical experience in quality, regulatory affairs or product development in medical devices or another regulated industryWorking knowledge of ISO 13485 and the EU Medical Device RegulationThe ability to structure complex topics, set priorities and take matters through to completionA self-directed, proactive and solution-oriented way of workingStrong written and spoken English skillsThe ability to collaborate with product development, management, partners and external experts Experience in one or more of the following is considered an advantage:MDR Class IIb medical devicesMedical device software or Software as a Medical DeviceISO 14971, IEC 62304, FDA or medical device cybersecurityTechnical documentation, clinical evaluation or post-market surveillanceAudits, CAPA processes or supplier qualityPRRC responsibilities or eligibilityProject or product managementPractical use of AI and automation in quality or documentation work Finnish language skills are a significant advantage but not an absolute requirement. What we offerA responsible and influential role at the core of a growing health technology companyA well-maintained quality system and structured handover from the current Quality ManagerThe opportunity to influence both our operating practices and future productsDirect involvement in quality, regulatory affairs, product development and international growthA compact and experienced team where your contribution has a visible impactThe opportunity to develop the use of AI and automation in quality managementA monthly salary of approximately €4,000–5,000, depending on relevant experience and level of responsibilityThe possibility to participate in Monidor’s option programmeFlexible hybrid work, with regular presence at our Oulu officeA permanent, full-time position starting as agreed Our Hiring process Please apply through LinkedIn by Sept 20th 2026 and attach your CV. A traditional cover letter is not required. We will ask you to briefly describe:Your personal responsibilities in an ISO 13485, MDR, FDA or other regulated environmentA quality or development matter that you personally took from an identified need through to completion We review applications continuously and may invite suitable candidates to discussions before the application deadline. The selection process is expected to include:A short introductory discussion or videoA structured interview with Monidor’s CEO and current Quality ManagerA brief, job-related case discussionA final discussion and reference checksWe aim to keep the process focused, transparent and timely. Application privacy Monidor Oy processes the personal data provided in your application solely for the purpose of carrying out this recruitment. Access is limited to the people participating in the selection process, and all applicant information is handled confidentially.Applicant data is retained only for as long as necessary for the recruitment process and related legal obligations. We will consider you for future positions only with your separate consent. Recruitment decisions are made by people and are not based solely on automated processing.For questions concerning the processing of applicant data or your data protection rights, please contact rekry@monidor.com.Learn more about Monidor at www.monidor.com.