Sunmedic AB jobb

Sunmedic is a medical device company focused on developing safe and effective products. We are looking for a hands-on Regulatory Affairs Expert who can take ownership of technical documentation, ensure regulatory compliance, and work closely with quality and development teams. What you will do - Prepare, maintain, and update technical files and regulatory documentation in line with EU MDR and other applicable regulations. - Handle regulatory submissions (EU MDR) and manage lifecycle activities including updates and variations. - Support and maintain the quality management system (ISO 13485), including quality control documentation and records. - Review and assess design changes, labeling updates, and material changes for regulatory impact. - Collaborate with Quality Assurance and R&D teams to ensure technical documentation is complete, accurate, and audit-ready. - Prepare for and support audits and inspections by notified bodies and competent authorities. - Contribute to post-market surveillance activities and the preparation of related reports (e.g., PMCF, PSUR). - Monitor regulatory updates and implement necessary changes in technical files and quality documentation. Who you are - A practical and detail-oriented regulatory professional who enjoys working directly with technical files and documentation. - Comfortable working in a fast-paced environment where you need to deliver concrete regulatory outputs. - Proactive in identifying compliance gaps and implementing practical solutions. - Clear communicator who can work effectively with Quality, R&D, and external auditors. What you have - Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field. - At least 2 years of ,hands-on regulatory affairs experience, in the medical device industry. - Solid experience preparing and maintaining, technical files, and working within a quality management system (ISO 13485). - Good knowledge of EU MDR requirements and regulatory submissions. - Strong organizational skills and attention to detail when managing documentation and multiple tasks. - Proficiency in English (written and spoken). Nice to have: - Experience with post-market surveillance and clinical evaluation reports. - Familiarity with US FDA 510(k) or UK MDR submissions. - Previous involvement in audits or inspections. What we offer - Competitive salary and benefits. - Flexible working arrangements. - The opportunity to work closely with product development and quality teams on real regulatory deliverables. How to apply Please send your CV and a short cover letter describing your experience with technical files, quality systems, and regulatory submissions, to [email protected]. Mention any specific documentation or projects you have worked on.

1) About the job Sunmedic is a forward-thinking medical device company dedicated to delivering innovative, safe, and effective products for patients. We are seeking a motivated Regulatory Affairs Expert to join our team and help ensure our products meet all regulatory requirements across markets. This role offers the opportunity to influence global regulatory strategies, collaborate with cross-functional teams, and contribute to bringing life-saving devices to patients. 2) What you will do - Develop and implement regulatory strategies for medical device products across markets, with a focus on MDR compliance. - Prepare, assemble, and submit regulatory documentation (technical files, PMCF/PSUR where applicable, EU MDR/UK MDR, 510(k) for the US, etc.) and manage lifecycle activities. - Monitor regulatory changes and provide guidance to product development teams to ensure ongoing compliance. - Liaise with competent authorities, notified bodies, and other external stakeholders; prepare for and support regulatory inspections and audits. - Maintain and update technical documentation, quality systems records, labeling, and essential performance documentation. - Lead regulatory risk assessments and material changes (design changes, new indications, claims, or intended uses) to determine regulatory impact. - Support post-market surveillance activities and compliance initiatives. - Provide regulatory training and mentorship to internal teams as needed. - Collaborate with Quality Assurance, Clinical, Pharmacovigilance, and Regulatory Operations to ensure coherent regulatory submissions and post-market commitments. 3) Who you are - You are a proactive, detail-oriented regulatory professional with a collaborative mindset. - You thrive in a fast-paced, cross-functional environment and can translate complex regulatory requirements into actionable plans. - You communicate clearly with internal teams and external stakeholders. - You are accountable, ethical, and committed to patient safety and product quality. 4) What you have - Education: Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Engineering, Pharmaceuticals, or a related field. - Experience: At least 2 years of hands-on regulatory affairs experience in the medical device industry. - Language: Proficiency in English (written and spoken). - Skills: - Knowledge of quality management systems (ISO 13485) and regulatory inspections. - Strong experience navigating regulatory frameworks, with emphasis on MDR (EU MDR) topics. - Ability to work with complex regulatory requirements and translate them into practical development plans. - Experience preparing regulatory submissions and managing lifecycle activities. - Familiarity with other markets (e.g., US 510(k), UK MDR) is a plus. - Excellent organizational and documentation skills; attention to detail; ability to manage multiple priorities. - Strong communication and teamwork capabilities. Nice-to-have (optional) - Experience with post-market surveillance, clinical evaluation reports, and safety reporting. - Project management experience or certification. What we offer - Competitive salary and benefits. - Flexible work arrangements and a collaborative, innovative culture. - Opportunities for professional growth and impactful work in the medical device field. How to apply Please submit your resume/CV and a brief cover letter outlining your regulatory experience and why you’re interested in Sunmedic. Include any relevant regulatory submissions or projects you’ve led.

Medical device Installer We believe in people and believe that success starts with the right people. That is why we value and mentor each member of our growing team. We seek young and talented, goal-oriented professionals who thrive to learn in a flexible but challenging work environment in an international medical device manufacturing company. Sunmedic AB is an innovative medical company working with a focus on advanced wound care products. We develop, produce, and sell our wound treatment products based on patients' essential requirements considering simplicity in the application of the appropriate treatments by healthcare professionals. What we are looking for in the role: We are looking for motivated and responsible small electrical device Installers (m/f) ready to learn and combine their knowledge with our way of performing the job in a medical device manufacturing environment. All our tasks at Sunmedic should be aligned with our respective quality systems and medical device manufacturing regulations. Your daily responsibilities will include: Work based on given installation plans and schemes Working with machines, fixtures, or measurement and test equipment Product cleaning and packaging During process inspections Installation/replacement of equipment Preparing the raw material for the process You are a perfect fit for this job if you have: Basic understanding of installation Good to work with small tools Good to work in a clean and controlled environment Basic knowledge of occupational safety and Independency in solving basic problems in the field of installation Developed organizational and communication skills Computer literacy and competence with MS Office applications Knowledge of the English language Thanks for all the applications. Sunmedic AB is an equal employment opportunity employer and welcomes all qualified applicants. We value diversity and the expertise that people from different backgrounds bring to our business. Come and join Sunmedic to create the transformative medical technology that enables our customers to care for a better and healthier world. All applications will be processed and stored following the protection of personal data and confidentiality. You can send your application through [email protected].

VI söker nu en administratör med gedigen erfarenhet av ekonomiadministration.I rollen kommer du att arbeta med administrativ och ekonomisk projektuppföljning samt vara en viktig stödfunktion för verksamheten. Du kommer att hantera projektadministration, fakturahantering, kundkontakter och ekonomisk uppföljning i nära samarbete med interna projektresurser och ekonomifunktioner. Arbetsuppgifter • Hantera inkommande ärenden via gemensam email • Registrera och administrera projekt i verksamhetens system • Tilldela projektresurser och samordna administrativ projektinformation • Hantera leverantörsfakturor inklusive kontering och attestflöden • Följa upp pågående projekt ur ett ekonomiskt perspektiv • Vidarefakturera kostnader till beställare och kunder • Följa upp kundfakturor och kundreskontra • Hantera påminnelser och utreda orsaker till uteblivna betalningar • Ha löpande kontakt med interna samordnare, projektmedarbetare och ekonomifunktioner • Kommunicera med externa kunder i ekonomirelaterade frågor Start: 2026-07-01 Om dig Vi söker dig som uppfyller nedan obligatoriska krav: • Eftergymnasial utbildning inom ekonomi • Minst 2 års erfarenhet av arbete med leverantörsfakturor och kundreskontra • Minst 2 års erfarenhet av arbete i Microsoft Office-paketet • Dokumenterad erfarenhet av ekonomisk administration och fakturahantering Det är meriterande om du även uppfyller följande krav: • Minst 2 års erfarenhet från offentlig sektor, exempelvis region, kommun eller myndighet Önskade personliga egenskaper: För att trivas och lyckas i rollen ser vi att du är en strukturerad och noggrann person som har lätt för att planera och prioritera ditt arbete. Du arbetar självständigt, tar ansvar för dina uppgifter och har ett lösningsorienterat förhållningssätt. Rollen innebär många kontaktytor, både internt och externt, vilket ställer krav på god samarbetsförmåga, ett professionellt bemötande och en tydlig kommunikation. Du är serviceinriktad, prestigelös och trivs i en administrativ roll där kvalitet, ordning och uppföljning är en naturlig del av vardagen. Samtidigt har du förmågan att hantera flera parallella arbetsuppgifter och behålla noggrannheten. Ansökan Låter uppdraget intressant? Skicka in din ansökan snarast då urvalsarbetet och intervjuer kommer ske löpande och tjänsten kan komma att tillsättas innan sista ansökningsdag. Du ansöker enkelt genom att skicka in ditt CV samt svara på några frågor. De kandidater som bäst matchar rollen kommer telefonintervjuas och sedan bli kallade till en intervju hos oss på Devotum. Nästa steg är en intervju hos vår kund. Referenstagning är en del av processen. Har du några frågor om uppdraget är du välkommen att höra av dig till ansvarig [email protected]