MDR Compliance Associate

AFRY AB

Företagsbeskrivning AFRY erbjuder tjänster inom teknik, design, digitalisering och rådgivning. Vi är hängivna experter inom industri, energi- och infrastruktur, som skapar värde för kommande generationer. AFRY har en global räckvidd med djupa rötter i Norden. Tillsammans accelererar vi omställningen till ett mer hållbart samhälle. Jobbeskrivning Vill du stötta företag i att säkerställa att deras produkter uppfyller krav och kan sättas på marknader över hela världen? Vi söker nu en konsult inom Product Compliance som vill arbeta nära våra kunder med produktregelverk, produktsäkerhet och kravtolkning. I rollen hjälper du organisationer att förstå vad regelverk innebär i praktiken – och hur de ska tillämpas i utveckling och lansering av produkter. I rollen kommer du bland annat: Arbeta med produktregelverk, produktsäkerhet och kravtolkning Tolka och omsätta standarder, direktiv och lagkrav till praktisk vägledning Stötta utvecklingsteam i frågor som rör regelverk inom teknik, säkerhet och hållbarhet Arbeta med CE-märkning och produktgodkännande för marknadstillträde Bevaka hur regelverk utvecklas och vad det innebär för produkter framåt Skapa och underhålla kvalitetsledningssystem   Vilka är vi?  Vår sektion Compliance & Quality Management (CQM) består av ca 20 medarbetare i Stockholm, Uppsala, Malmö och Göteborg. Bland våra medarbetare som är allt från nyexaminerade till seniora, finns en bred kompetens inom kvalitet, product compliance och verksamhetsutveckling. Vi arbetar med produkter i hela dess livscykel samt processer i hela företagets organisation i olika branscher och organisationer.   Kvalifikationer Vi ser gärna att du har: Relevant högskoleutbildning inom teknik, miljö eller motsvarande Minst 3-5 års erfarenhet av arbete med produktlagstiftning, gärna inom tillverkande industri eller som konsult God kunskap om ett eller flera av följande regelverk: batteriförordningen, maskindirektivet/-förordningen, produktsäkerhetsförordningen, REACH, RoHS, Lågspänningsdirektivet (LVD), EMC, Radioutrustning (RED), Tryckkärlsdirektivet, Medicintekniska produkter (MDR/IVDR, ISO 13485, QMSR) Förmåga att tolka och tillämpa EU-lagstiftning i praktiken Flytande svenska och engelska i tal och skrift  Det är inte ett krav att du har arbetat med alla områden ovan – viktigare är att du har erfarenhet av att arbeta med produktregelverk och är van att sätta dig in i nya standarder, direktiv och lagkrav. Vår konsultgrupp präglas av samarbete, öppenhet, professionalism och vi drivs av att skapa mervärde för våra kunder. Vårt affärsområde kan utöver konsulttjänster även erbjuda våra kunder paketerade lösningar och produkter. Ytterligare information Vi erbjuder en arbetsplats med framåtanda och trygghet i form av kollektivavtal och personalförmåner för samtliga av våra medarbetare. Vår personalklubb arrangerar sociala aktiviteter på och utanför kontoret. Allt från skidresor, sjunga i kör till att spela brädspel – det finns något för alla. Kontaktuppgifter för frågor: För frågor gällande tjänsten, kontakta Sales Area Manager Lars Bjernevall,  lars.bjernevall@afry.com (mailto:lars.bjernevall@afry.com) För frågor gällande rekryteringsprocessen, kontakta Rekryteringspartner Fanny Sjödell, fanny.sjodell@afry.com (mailto:fanny.sjodell@afry.com)   För samtliga rekryteringar på AFRY genomförs som grund alltid en ID-kontroll, referenstagning samt verifiering av utbildning. Sista ansökningsdag är 9 augusti. Det går bra att skicka in din ansökan tidigare men vi kommer gå igenom majoriteten av ansökningarna först efter sommarledigheten. Vi ser att du ansöker via ansökningsknappen då vi inte kan ta emot ansökningar via mejl. Vi undanber oss direktkontakt med bemannings- och rekryteringsföretag samt säljare av ytterligare jobbannonser.   På AFRY driver vi förändring i allt vi gör. Vi anser att förändring sker när modiga idéer möts, när vi samarbetar, skapar innovation och omfamnar kreativa lösningar, det är så vi skapar framtiden. Vi söker konstant kvalificerade kandidater som vill ansluta sig till våra inkluderande  team runt om i världen. Bli en del av oss och påskynda den gröna omställningen

Neko Health AB

Role Purpose As Medical Director in Sweden, you will be the principal medical authority across our Swedish sites. Accountable for clinical performance, governance, quality, team leadership, and the credibility of Neko’s clinical model. You will report to the Medical Director, Europe and work closely with the international medical leadership team. You will have a visible, active presence in the clinics. Hold the clinical standard with consistency and clarity and build a strong clinical team culture together with the Swedish clinical leads. Beyond the clinics, you are Neko’s medical voice in Sweden. You will engage with academic institutions, regulatory bodies, professional networks, and public health discourse. Representing a model of preventive care that is evidence-based, and genuinely different from what the system currently offers. What You’ll Deliver in the First 6–12 Months Clinical Leadership and Team Performance Set and hold the clinical standard for Neko’s Swedish operations. Lead, develop, and performance-manage Sweden's clinical leads. Create a culture of clinical excellence, high expectations, and honest feedback. Partner closely with Sweden's operational and clinical teams to ensure the two sides of the business move in the same direction without friction. Ensure clinical KPIs. Clinical Governance and Quality Own the Swedish clinical governance framework: policies, protocols, escalation pathways, incident review, and risk management, aligned to Neko’s global standards and Swedish regulatory requirements. Own Sweden’s clinical quality composite and drive it consistently to benchmark. Lead Neko Sweden’s continuous quality assurance efforts across patient safety and medical quality. Contribute actively to the global medical quality framework, bringing Swedish market insight into shared standards and improvement initiatives. Regulatory and Compliance Leadership Responsible for ensuring that all Swedish Neko clinics operate in compliance with applicable Swedish healthcare laws and regulations. Maintain Neko’s relationship with relevant Swedish regulatory and professional bodies. Ensure clinical documentation, consent frameworks, and protocols are compliant with Swedish healthcare law, EU MDR, and GDPR. Ensure Neko’s Swedish clinical operations are prepared for regulatory inspection at all times. Clinical Evidence and Medical Community Engagement Help build the clinical case for Neko’s preventive model in Sweden’s medical and public health discourse. Engaging with academic institutions, research bodies, and clinical networks. Ensure that the clinical claims Neko makes are grounded in evidence. Build and maintain Neko’s clinical credibility in the Swedish medical community. Be a recognized and respected voice on preventive medicine, population health, and the clinical value of early detection. Engage with Swedish academic medicine, public health institutions, and professional bodies. Represent Neko at medical conferences, academic and policy forums, and in media engagement on preventive health. Minimum Qualifications Swedish medical license issued by Socialstyrelsen. 10+ years of clinical experience, including 3–5 years in a senior clinical leadership role with direct management of clinical teams. Demonstrable track record of managing, developing, and performance-managing clinicians. Strong knowledge of Swedish healthcare regulations. A senior physician with a standing in the Swedish medical community. A genuine belief in preventive medicine and early detection. Fluency in Swedish and English. Preferred Experience in technology-enabled, consumer-facing, or multi-site private healthcare environments. Familiarity with Swedish private healthcare, Företagshälsovård, and corporate wellness markets. Track record of external profile-building: published clinical or scientific work, speaking engagements, advisory roles, or media presence on population health. Experience leading a clinical function through significant growth or operational scaling.

OIO Väst AB

About the position As a Global Regulatory Specialist, you will join our client's global Quality & Regulatory Affairs function and play a key role in ensuring that medical devices and mounting systems comply with regulatory requirements across international markets. You will become part of a central regulatory team based in Stockholm, supporting a global organization that operates in more than 80 countries and holds a market-leading position within assistive communication solutions. The role combines operational responsibilities with strategic influence. While maintaining existing regulatory processes, you will also support the organization by interpreting regulatory changes, providing expert guidance, and ensuring continued market access for the company's products. Key responsibilities: Maintain and improve technical documentation, including Annex II & III documentation and EU Declarations of Conformity. Coordinate product registrations and device listings with regulatory authorities, including the FDA, Authorized Representatives, and distributors. Support regulatory compliance activities related to EU MDR Class I products and FDA 510(k)-exempt Class II devices. Review device classifications and assess regulatory implications across global markets. Coordinate internal and external audits and support audit readiness activities. Monitor changes in global regulatory requirements and communicate their impact throughout the organization. Collaborate closely with Product Development, Quality, Operations, and other cross-functional teams to ensure regulatory compliance throughout the product lifecycle. This is a highly collaborative global role with frequent interaction with colleagues across Europe, North America, Asia, and Australia. While most collaboration takes place virtually, occasional international travel may occur, primarily within Europe. We are looking for someone whoHolds a Bachelor's degree in Regulatory Affairs, Life Sciences, Electrical Engineering, Electronics, or a related field. Has at least five years of experience working within Medical Device Regulatory Affairs. Has solid hands-on experience with EU MDR (Class I) and FDA Quality System Regulations (QSR). Has experience working with regulatory systems, document management tools, QMS platforms, technical documentation, and regulatory audits. Is comfortable interpreting complex regulatory requirements and translating them into practical guidance for different stakeholders. Communicates fluently in English, both verbally and in writing. Experience working with embedded systems, IEC 62304, EU MDR Class II/III products, or additional languages such as German is considered highly meritorious. We believe you areOur client place great emphasis on personal qualities, as success in this role depends on your ability to work collaboratively across a global organization while maintaining high regulatory standards. You are analytical, structured, and patient, with a genuine interest in understanding evolving regulations and staying up to date with industry developments. You enjoy reading, interpreting, and applying complex regulatory documentation and are comfortable working independently while supporting stakeholders throughout the business. You are confident in communicating regulatory requirements and able to influence others through facts and expertise. Rather than seeking a managerial position, you enjoy being the subject matter expert that colleagues rely on when navigating regulatory challenges. Curiosity and a willingness to continuously learn are highly valued, as regulations continue to evolve across global markets. About the partner company Our client is a global MedTech company headquartered in Stockholm and a world leader within assistive communication solutions. Every day, their products empower people with disabilities to communicate, connect with others, and live more independent lives. With approximately 1,400 employees worldwide, the company operates across multiple international markets and develops innovative medical devices used both in healthcare environments and at home. Their products hold a leading global market position, and regulatory compliance plays a critical role in ensuring continued market access across different regions. The Quality & Regulatory Affairs function is centrally located in Stockholm and collaborates closely with colleagues across Europe, North America, Asia, and Australia. You will join an experienced international organization where expertise, collaboration, and continuous learning are highly valued. About the employment This is a consulting assignment with employment through OIO. The assignment is expected to run for 6-12 months, with excellent opportunities for a permanent position with the client if both parties are satisfied. Scope: Full-time Start: August 2026 (for the right candidate, some flexibility is available) Location: Stockholm, Östermalm (hybrid, 1-3 days per week in the office) Working hours: Primarily office hours with flexible working arrangements Salary: Fixed monthly salary Apply today! Submit your application as soon as possible, as we review candidates continuously and the advertisement may close before the recruitment process is completed. About OIO Our passion is helping people find the right role and workplace. At the same time, we understand that choosing your next career move is an important decision. That's why we dedicate ourselves to getting to know both our candidates and their ambitions throughout the recruitment process. We believe that people have the greatest opportunity to reach their full potential when they're in the right environment. Through fair employment terms, close leadership, and continuous support, we actively contribute to your engagement and professional development. We are as picky as you are.