Regulatory Lead - Medical Device Software

RaySearch Laboratories AB (publ)

RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe and Asia - Pacific. Today we are more than 400 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination. Are you an experienced regulatory leader who enjoys developing people, improving processes, and driving regulatory excellence in a global medical device environment? Then this could be the right role for you.About the role We are looking for an experienced Regulatory Affairs Manager to lead a team of 5 Regulatory Affairs Specialists supporting our global medical device portfolio. This is a key leadership role for someone who combines deep global regulatory expertise with proven people leadership. You will lead and develop a team responsible for global regulatory submissions and registrations, regulatory compliance, vigilance, post-market regulatory activities, and regulatory intelligence. Success in this role requires a leader who is strategic, pragmatic, hands-on, and passionate about developing people while driving operational excellence.   What you'll do   Manage a team of 5 Regulatory Affairs Specialists.   Manage resource planning and allocation across global regulatory activities.   Ensure high-quality execution of global regulatory submissions, product registrations, and other regulatory operational activities.   Own and continuously improve core regulatory processes and ways of working.   Support global post-market regulatory activities, including vigilance, Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSURs), regulatory compliance, and regulatory intelligence.   Provide technical guidance and hands-on support to the team on complex regulatory matters.   Foster a collaborative, engaged, and high-performing team focused on delivering regulatory excellence.  Your profile  You are an experienced regulatory leader with a passion for developing people, improving processes, and supporting a global medical device organization. You are a pragmatic and collaborative leader who translates regulatory requirements into practical, efficient processes that ensure compliance while supporting the business. You thrive in dynamic environments, focus on what matters most, build strong cross-functional relationships, and are motivated by developing talent and driving the continued success of the organization. Experience & skills  Extensive Regulatory Affairs experience within the medical device industry,   Proven people management experience, with the ability to lead, coach, and develop regulatory professionals.  Expert knowledge of the European Medical Device Regulation (EU MDR).   Demonstrated experience leading global regulatory submissions and product registrations, experience with at least one of the following regulatory authorities is required: China (NMPA), Japan (PMDA), India (CDSCO), US (FDA)   Experience with medical device software and IEC 62304.   Experience with medical device standards such as ISO 13485 and ISO 14971.  Strong understanding of global medical device regulations throughout the product lifecycle, including medical device product development and design control processes.  Demonstrated ability to optimize regulatory operations, improve processes, and lead teams through organizational change.   Excellent planning, prioritization, and stakeholder management skills.   A pragmatic, positive, and solution-oriented leader who leads by example, takes ownership, and thrives in a dynamic environment.   Proficiency in English.  Meriting experience  US regulatory experience, Experience with FDA submissions, including eSTAR/510(k).  Experience with IEC 62366 and ISO 14155  Experience with regulatory intelligence, regulatory signal monitoring, and evolving global regulatory requirements.   Experience with Cybersecurity requirements for medical devices.  Experience with AI/ML-enabled medical devices.  Our Culture Culture at RaySearch is the driving force behind our organization, where everything we do is driven by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their field, driven by a relentless focus on solving problems - no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care. Our Offer At RaySearch, we offer a diverse and inclusive work environment, fostering openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day. Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes attached with a competitive compensation and benefits package. Application Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail.

Blykalla AB

Blykalla is scaling rapidly to industrialize our next-generation small modular reactor (SMR) technology. If you are passionate about nuclear technology and want to make a real impact on the future of clean energy, we’d love to hear from you. Do you thrive on solving complex chemical and material challenges through hands-on experimentation and analytical thinking? We are looking for a Nuclear Waste Chemist - an experimentalist role to help develop Blykalla’s backend chemistry and waste management strategies for our lead-cooled SMR technology. In this role, you will combine experimental R&D, technical analysis, and cross-functional collaboration to support areas such as waste minimization, coolant purification, material reuse, spent nuclear fuel (SNF) handling and backend system development. This is an opportunity to help build both the technical foundations and laboratory capabilities for one of Europe’s most advanced nuclear startups. What we do at Blykalla Blykalla is developing the next generation of nuclear technology through advanced Small Modular Reactors (SMRs) based on innovative fuel, materials, and reactor designs. As Sweden’s leading SMR developer, our mission is to decarbonize industry and provide safe, scalable, and sustainable energy solutions. Our reactors use uranium nitride fuel and lead coolant, creating unique opportunities and challenges across fuel cycle chemistry, coolant purification, and waste management. What You'll Do You will play a key role in building Blykalla’s experimental capabilities related to backend systems and nuclear waste management. Your responsibilities include: Help establish and develop Blykalla’s in-house chemistry laboratory and experimental capabilities. Design, plan, and perform experiments related to waste treatment, coolant purification, and material handling. Troubleshoot experimental systems, identify suitable analytical methods, and independently drive investigations forward. Contribute to technical reports, feasibility studies, licensing documentation, and strategic decision-making. Investigate opportunities to reduce low-, intermediate-, and high-level waste volumes through purification strategies, system design, and material choices. Analyze and evaluate expected waste streams, both solid and liquid, based on reactor operating conditions and system design. Evaluate treatment, purification, recycling, and waste management methods for Pb coolant, activated materials, and SNF, including contamination control and backend management considerations. Work closely with national laboratories, industrial partners, and regulators to turn research into deployable solutions. Act as an internal technical resource for chemistry-related questions across the waste lifecycle and backend systems. Who You Are You are analytical, hands-on, and motivated by solving difficult technical problems. You enjoy experimental work and are comfortable navigating uncertainty in a fast-moving R&D environment. You are someone who can combine theory with practical execution — designing experiments, troubleshooting equipment and processes, analyzing data, and communicating results clearly. Even when facing unfamiliar systems or analytical methods, you know how to identify the right tools, techniques, and collaborators to move forward. You work well across disciplines, communicate effectively, and enjoy building new capabilities from the ground up. Above all, you want to contribute to meaningful long-term solutions in clean energy and nuclear technology. We Believe You Have MSc or PhD in chemistry, radiochemistry, chemical engineering, materials science, or a related field For MSc candidates: approximately 2+ years of relevant industry or research experience Hands-on chemical wet lab experience, including designing and executing experimental setups and evaluating chemical processes Strong analytical skills, with the ability to structure, interpret, and present complex data clearly Strong technical writing and communication skills Experience collaborating with research facilities, laboratories, industrial partners, or technical vendors Fluent in English, written and spoken The Following is Considered a Big Plus Knowledge of lead chemistry, fuel chemistry, actinide behavior, or fission product separation Experience with radioactive or hazardous waste systems Familiarity with coolant purification or backend fuel cycle systems Experience with waste classification frameworks or nuclear waste management strategies Experience writing technical reports for licensing, feasibility studies, or regulatory applications Experience with programming, scripting, or modeling for scientific and technical applications Location The position is based in Stockholm, Sweden, with occasional travel to partner laboratories and industrial sites. So, What Do You Think? Join us in transforming nuclear energy and building a more sustainable future. At Blykalla, you’ll work alongside ambitious engineers and scientists solving some of the most important energy challenges of our time — developing safe, clean, and reliable power systems for the future. We are proud to foster an inclusive workplace free from discrimination. We believe diversity of experience, perspectives, and backgrounds creates stronger teams, better technology, and a better workplace for everyone. We encourage applicants from all backgrounds to apply.

Plantvision AB

Vill du vara med och säkerställa kvaliteten inom Life Science tillsammans med branschens skarpaste hjärnor? Då är det här du ska vara. Hos oss väntar uppdrag som kräver nyfikenhet, lösningsdriv och vass kompetens och som ger dig chansen att utvecklas i nya sammanhang. Tillsammans bidrar vi till en bättre morgondag och formar framtidens lösningar som gör skillnad för människor och samhälle. Det här blir din roll Som QA/RA (Quality Assurance och Regulatory Affairs) -konsult hos oss blir du en nyckelperson för våra kunder. Du stöttar dem genom hela produktens livscykel – från utveckling av kvalitetsledningssystem till framtagning av teknisk dokumentation. Du får stort utrymme att påverka din egen utveckling och möjlighet att leda eller delta i projekt som gör verklig skillnad. I rollen ingår bland annat att: - Utforma regulatoriska strategier och guida kunder i komplexa regelverk (EU MDR/IVDR, FDA, MDSAP m.fl.). - Arbeta med regulatoriska ansökningar, submissions och interaktion med myndigheter och notified bodies. - Säkerställa effektiva processer och rutiner. - Säkerställa korrekt och komplett teknisk dokumentation. - Bidra till klinisk och prestandautvärdering samt implementering av tillämpliga standarder. - Vara en aktiv del i utvecklingsprojekt där regulatoriska krav måste integreras tidigt. - Dela kunskap och bygga kompetens tillsammans med vårt erfarna RA-team. Så här kommer du att briljera Du har förmågan att göra komplexa regulatoriska krav begripliga och skapar förtroende genom din kommunikativa stil. Du är noggrann, lösningsorienterad och trivs i en roll där du växlar mellan strategiskt tänkande och praktiskt genomförande. För att lyckas i rollen har du: - Minst 3 års erfarenhet av QA/RA inom medicinteknik eller IVD. - Högskole- eller universitetsexamen inom Life Science (t.ex. civilingenjör, BMA eller PhD). - Erfarenhet av att skriva och uppdatera teknisk dokumentation enligt MDR/IVDR samt klinisk/prestandautvärdering. - Erfarenhet av att skriva och anpassa processer enligt MDR/IVDR och ISO 13485. - Mycket goda språkkunskaper i svenska och engelska. - Dokumenterad erfarenhet inom ett eller flera av följande områden: EU MDR/IVDR och tillhörande vägledningar. - FDA-ansökningar (510(k), De Novo, PMA) och andra regulatoriska pathways. - MDSAP och internationella regulatoriska krav. - Standarder för riskhantering, säkerhet och prestanda (ISO 14971, IEC 60601, IEC 62366, ISO 15189). Att vara en del av Team PV Vi är ett konsultbolag som brinner för Life Science, från MedTech-startups till globala läkemedelsbolag. Hos oss får du följa hela kedjan, från tillverkning till vård, och arbeta med regelverk, revisioner, projektledning och utvärderingar. Det som driver oss är att hjälpa kunder nå sina mål och göra verklig skillnad för patienter och samhälle. Hos oss får du något annorlunda. Vi skiljer oss från traditionella konsultbolag genom vår unika kultur, den sticker ut och genomsyrar allt vi gör och vi är extremt stolta över att vara ett Great Place To Work, år efter år. Vissa säger att en kultur sitter i väggarna. Om vår hade gjort det, hade vi haft mjuka väggar. Välkommen till oss på Plantvision! Ansökan Under semesterperioden kan det dröja något längre innan du hör ifrån oss. Vi påbörjar arbetet med urval och intervjuer så snart vi är tillbaks från ledigheten. Om du har frågor om denna tjänst, välkommen att kontakta Pascal Skoglund på 072 566 99 87 eller Pascal.Skoglund@plantvision.se Har du eget bolag och är intresserad av att samarbeta med oss som underkonsult? I stället för att söka en specifik tjänst, connecta gärna med oss via vår karriärsida och ange att du är intresserad av att gå som underkonsult – så hör vi av oss när något passande dyker upp.