Quality & Regulatory Affairs Manager – Medical Devices

Monidor Oy; Oulu; Hybrid; EUR 45,000 - 56,000; Full time

Benefits offered by this job

Option programme

Flexible hybrid work

Job summary

Monidor Oy in Oulu is seeking a Quality & Regulatory Affairs Manager to own ISO 13485 quality management and EU regulatory activities. The role can include work on development projects and product initiatives within a mature QARA environment.

You will coordinate audits, support post-market surveillance, and guide software releases with a focus on compliance and safety. We offer a competitive monthly salary (€4,000–€5,000), hybrid work with regular presence at the Oulu office, and a path towards

Qualifications

• Relevant BSc or MSc in engineering, technology, life sciences or similar.
• Experience in quality/regulatory or product development in medical devices or regulated industries.
• Working knowledge of ISO 13485 and EU Medical Device Regulation.

Responsibilities

• Maintain and continuously improve ISO 13485 quality management system.
• Ensure compliance with EU MDR and other requirements.
• Coordinate internal and external audits and liaison with notified bodies.

Skills

English proficiency

ISO 13485 knowledge

EU Medical Device Regulation

Quality management

Audit coordination

Education

BSc/MSc in engineering or life sciences

Job description

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 Role

You 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 system
• Ensuring compliance with the EU Medical Device Regulation and other applicable requirements
• Coordinating internal and external audits
• Working with the notified body, authorities, suppliers and external experts
• Managing CAPAs, nonconformities, change control and supplier quality
• Supporting risk management and maintaining technical documentation
• Coordinating post-market surveillance, feedback and vigilance activities
• Bringing practical quality and regulatory guidance into product development and software releases
• Supporting third‑party medical device integrations and the development of smart algorithms and AI‑assisted reporting
• Training and supporting the team in quality‑related matters
• Leading 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 for

You 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 field
• Practical experience in quality, regulatory affairs or product development in medical devices or another regulated industry
• Working knowledge of ISO 13485 and the EU Medical Device Regulation
• The ability to structure complex topics, set priorities and take matters through to completion
• A self‑directed, proactive and solution‑oriented way of working
• Strong written and spoken English skills
• The ability to collaborate with product development, management, partners and external experts

Experience in one or more of the following is considered an advantage:

• Medical device software or Software as a Medical Device
• ISO 14971, IEC 62304, FDA or medical device cybersecurity
• Technical documentation, clinical evaluation or post‑market surveillance
• PRRC responsibilities or eligibility
• Project or product management
• Practical use of AI and automation in quality or documentation work

Finnish language skills are a significant advantage but not an absolute requirement.

What we offer

• A responsible and influential role at the core of a growing health technology company
• A well‑maintained quality system and structured handover from the current Quality Manager
• The opportunity to influence both our operating practices and future products
• Direct involvement in quality, regulatory affairs, product development and international growth
• A compact and experienced team where your contribution has a visible impact
• The opportunity to develop the use of AI and automation in quality management
• A monthly salary of approximately €4,000–5,000, depending on relevant experience and level of responsibility
• The possibility to participate in Monidor’s option programme
• Flexible hybrid work, with regular presence at our Oulu office

A permanent, full‑time position starting as agreed

Our Hiring process

We will ask you to briefly describe:

• Your personal responsibilities in an ISO 13485, MDR, FDA or other regulated environment
• A 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 video
• A structured interview with Monidor’s CEO and current Quality Manager
• A brief, job‑related case discussion
• A final discussion and reference checks

We 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 [e-mail].