Senior Risk Management Specialist

Oticon Medical BAHS specializes in developing, producing, and distributing advanced bone-anchored hearing systems, including long-term implants, sound processors, software, and surgical tools. We are a global leader in hearing solutions, and we are currently looking for a Senior Risk Management specialist to lead and continuously improve our risk management framework while working hands-on with product teams across the entire product lifecycle This is a unique opportunity to combine strategic process ownership with operational execution. You will own the company's risk management process and, at the same time, actively support development projects, product maintenance activities, software development initiatives, and cybersecurity assessments. Your expertise will help ensure that our products remain safe, effective, and compliant while enabling innovation that improves people's quality of life. You will work closely with colleagues across R&D, Regulatory Affairs, Quality Assurance, Clinical Affairs, Operations and Product Management. The role offers a unique combination of strategic influence and hands-on involvement, allowing you to shape both how risk management is performed and how it is applied to real products. This position can be placed either at our site in Gothenburg, Sweden, Copenhagen, Denmark or Vallauris, France. Key Responsibilities:

• Own and improve the company's Risk Management process, ensuring it meets applicable medical device regulations and standards.
• Act as the subject matter expert for medical device risk management and maintain relevant QMS documentation, procedures, and training materials.
• Lead risk management activities throughout the product lifecycle, including hazard identification, risk assessments, benefit-risk evaluations, and risk control measures.
• Maintain and review Risk Management Files (RMFs), ensuring documentation is up to date and identified actions are followed through.
• Ensure risk management is integrated into product development and other key processes, including change control, CAPA, complaints, and post-market surveillance.
• Work closely with software and engineering teams to identify and assess software-related risks and cybersecurity threats, and ensure appropriate controls are in place.
• Provide training and guidance to project teams and colleagues to support consistent risk management practices across the organization.

Your profile: You are equally comfortable discussing high-level process improvements with department leaders as you are facilitating a detailed risk analysis with project teams. You enjoy bringing structure to complex problems, building consensus across functions, and translating regulatory expectations into practical and effective solutions. Most importantly, you are motivated by ensuring that patients can rely on safe and effective products. Required Qualifications:

• Bachelor's degree or higher in Engineering, Medical Technology, Life Sciences, Quality, Regulatory Affairs, Software Engineering, or a related discipline.
• Experience working with risk management activities in the medical device industry.
• Strong knowledge of ISO 14971 and medical device risk management principles.
• Experience facilitating cross-functional risk management discussions and workshops.
• Understanding of software development processes and software risk management.
• Strong communication, facilitation, and training skills.
• Structured, analytical, and detail-oriented approach to work.

Preferred Qualifications

• Experience owning or managing quality system processes.
• Experience with software-containing or connected medical devices.
• Experience with cybersecurity risk management for medical devices.
• Knowledge of IEC 62304 and applicable cybersecurity standards or guidance.
• Experience supporting audits, inspections, or notified body assessments.
• Experience working in a global and cross-functional environment.

Why Oticon Medical? At Oticon Medical collaboration is our greatest strength, as we believe the best results come from a team-driven approach. We foster a culture of trust, openness, respect, and kindness. We also offer flexible working conditions and prioritize work-life balance. By joining our growing global company, you will directly contribute to enhancing the lives of individuals worldwide. Interested? Submit your application and CV through our online recruitment system. Please note that we do not accept applications via email. Applications will be reviewed continuously, and the recruitment process may close before the stated deadline of 2026-12-06. We look forward to hearing from you!