Product Quality & Post-Market Surveillance Specialist

We are looking for an ambitious and detail-oriented individual to join our Quality & Regulatory Affairs team, which is responsible for ensuring the ongoing safety, performance, and compliance of our medical devices throughout their lifecycle.

The Product Quality & Post-Market Surveillance Specialist will play a key role in maintaining and continuously improving our post-market surveillance system, with a strong focus on analyzing product performance data to generate insights that drive quality improvements and ensure patient safety. This role combines data analysis with regulatory compliance, ensuring that product performance and safety are proactively monitored across all markets. The position involves cross-functional collaboration and contributes directly to regulatory compliance, product improvement, and evidence-based decision-making.

Function & Responsibilities

• Lead and maintain the Post-Market Surveillance (PMS) system in alignment with EU MDR and applicable global requirements
• Develop, update, and maintain PMS Plans for assigned products, including data sources, methodologies, and reporting timelines
• Prepare PMS Reports and Periodic Safety Update Reports (PSURs), as applicable
• Coordinate the cross-functional PMS/PSUR input and review cycle, including data collection, timelines, and stakeholder alignment
• Analyze post-market data (e.g., complaints, service data, nonconformities, vigilance data, and customer feedback) to assess product quality and performance
• Perform trending and statistical analysis to identify adverse trends, emerging risks, and potential safety concerns, and escalate as required
• Develop and maintain KPIs and dashboards to monitor product quality and post-market performance
• Ensure PMS outputs are integrated into relevant Quality Management System (QMS) processes, including CAPA, risk management, and management review
• Collaborate with cross-functional teams such as R&D, Regulatory Affairs, Manufacturing, Supplier Quality, and Customer Support to assess findings and define follow-up actions
• Support updates to risk management documentation (ISO 14971) based on post-market data
• Participate in audits and inspections as a subject matter expert for PMS and support responses and corrective actions as needed
• Monitor changes in post-market regulatory requirements and contribute to implementation and continuous improvement activities

Education and Qualification Requirements

• B.Sc. or M.Sc. degree in Engineering, Life Sciences, Quality, Statistics, or a related field, or equivalent hands-on experience in a relevant role
• Experience in medical device quality, post-market surveillance, vigilance, or related QA/RA roles is considered an advantage
• Experience preparing PMS documentation such as PMS Plans, PMS Reports, and PSURs is a plus
• Familiarity with EU MDR post-market requirements and/or global PMS expectations is beneficial
• Understanding of Quality Management Systems (ISO 13485) and risk management (ISO 14971) is an advantage
• Strong analytical and problem-solving skills, with an interest in data analysis and trending
• Proficiency in Excel and data analysis tools; experience with dashboards or BI tools is a plus
• Excellent English skills, both verbal and written

The right person for the position

• You have strong analytical skills and enjoy working with data to identify trends and insights
• You are detail-oriented and structured, with a focus on quality and compliance
• You have good communication skills and enjoy working in a cross-functional, collaborative environment
• You are proactive and able to work independently while managing multiple priorities
• You are comfortable navigating complex requirements and contributing to continuous improvement

The job application, CV, and cover letter may be submitted in English or Icelandic.

We are always interested in talented individuals who share our passion for improving people’s lives. Nox Medical embraces diversity. As an equal opportunities employer, we believe the foundation of our dynamic and pioneering spirit starts with a fair and inclusive culture. Our company culture focuses on bringing unique ideas and people together to spark innovation and teamwork.