Regulatory Product Surveillance Specialist

Freelio; Denmark; Hybrid; DKK 720,000 - 960,000; Full time

Job summary

GN Hearing A/S i Danmark søger en Regulatory Product Surveillance Specialist til at understøtte sikkerheds- og klinisk overholdelse af høreapparatløsninger. Du vil håndtere sikkerhedsfeedback, MDR/vigilance rapportering og kliniske vurderinger i samarbejde med Corporate Quality.

Stillingen kræver sundhedsfaglig kvalifikation og erfaring som medicinsk rådgiver eller konsulent samt stærk viden om regulativer for medicinsk udstyr. Kommunikation på engelsk forventes som en kærnekompetence.

Qualifications

• Sundhedsfaglig kvalifikation (f.eks. læge, klinisk videnskabsmand, audiolog)
• Erfaring som medicinsk rådgiver eller konsulent
• Stærk viden om medicinsk udstyrsreguleringer og relevante standarder
• Evne til at formidle klinisk perspektiv klart
• Engelsk kommunikation skriftligt og mundtligt

Responsibilities

• Håndtere sikkerhedsrelateret kundefeedback
• MDR/vigilance rapportering inden for gældende regler
• Sikre overholdelse af post-market og vigilance procedurer
• Udføre kliniske vurderinger til støtte for sikkerheds- og regulatoriske beslutninger
• Give medicinsk input til klagesager og risikostyring
• Deltage i audits og inspektioner og understøtte audit readiness

Skills

Medical knowledge

Regulatory knowledge

Clinical communication

Education

Healthcare professional qualification

Job description

# Regulatory Product Surveillance SpecialistAnsøg hos virksomhedenAnsøgningsfrist: 29. september 2026## JobbeskrivelseSupporting the safety and clinical compliance of Hearing solutions – Sound like you?In the role of Regulatory Product Surveillance Specialist for the Safety and Clinical Council, within Corporate Quality department, you will contribute to our purpose of Bringing People Closer. You will support post-market surveillance and vigilance activities, while contributing to medical device compliance across relevant areas.The Team you will be part of:You will join a team of specialists in Post-Market Surveillance, Vigilance and Usability Engineering within GN Hearing A/S. The team works with complex regulatory matters to help ensure compliant, user-centered products for people with hearing loss.We are a collaborative and quality-focused team that values continuous learning, curiosity and respectful dialogue. We welcome diverse perspectives and work closely together to find sound, practical solutions.Your contribution is appreciated, and you will:•Manage safety-related customer feedback•MDR/Vigilance reporting within applicable regulatory framework•Ensure regulatory compliance of post market and vigilance procedures•Perform clinical assessments to support product safety and regulatory decisions•Provide medical input to support complaint handling and risk management decisions•Participate in audits and inspections and support ongoing audit readinessTo perform well in the role, we imagine that you:•Hold a healthcare professional qualification - medical doctor, clinical scientist, audiologist or equivalent•Have experience working as medical advisor, medical consultant or similar•Have solid knowledge of medical device regulations and applicable standards•Are comfortable working independently while collaborating effectively in multidisciplinary settings•Have ability and interest of counseling and communicating clinical perspective in an approachable manner•Communicate clearly and confidently in English, both written and spokenWe support flexible working whenever possible and trust our people to balance flexibility with the need for in-person collaboration.We encourage you to applyEven if you do not match every qualification, we welcome your application if you believe you bring relevant transferable skills. We value mindset and motivation alongside experience, and we are committed to supporting your growth as well as that of your team and the wider GN organization.We are focused on an inclusive recruitment processAll applicants will receive equal consideration for employment. We encourage you to submit your application without a photo to support an equal application process.If you have any special requirements for the interview, please let the Hiring Manager know when accepting the invitation.How to apply?Use the ‘APPLY’ link no later than September 28, 2026.Feel free to only submit your up-to-date CV, including a few sentences outlining your motivation for applying.We review applications on a continuous basis, so we encourage you to apply as soon as possible. Please note that the role may be closed before the deadline once we have identified the candidate to hireJoin us in bringing people closerGN brings people closer through our intelligent hearing, audio, video, and gaming solutions. Inspired by people and motivated by innovation, we create technology that enhances hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and deliver great experiences for audio and gaming users.GN Store Nord A/S has entered into a definitive agreement for the sale of GN’s Hearing business to Amplifon S.p.A. to create a global leader in audiology. For GN Group, this creates an opportunity to expand our position in the large audio and video peripherals markets. Read more about the announcement here. We hope you will join us on this journey and look forward to receiving your application. #LI-GNGroup