Regulatory Affairs Support Specialist hos RaySearch i Stockholm
Ansvarar för regulatoriska bevakningsaktiviteter, rapporterar incidenter och stödjer registreringsprocesser på globala marknader. Kräver högskoleexamen inom livsvetenskap eller teknik samt 2 års erfarenhet av regulatoriska frågor inom medicinteknik.
Titel, arbetsplatsens namn och sammanfattning skrivna av AI utifrån annonsen.
Bra att veta
Lön
Inom yrkesgruppen Farmakologer och biomedicinare har de som jobbar i privat sektor i Stockholm i snitt 78 700 kr i månaden, varav 76 000 kr i grundlön. I hela landet, i privat sektor, tjänar hälften mellan 54 300 kr och 82 200 kr. Det är statistik för yrket, inte vad den här arbetsgivaren betalar.
Källa: SCB, lönestrukturstatistik 2025
Anställningen
Anställningen har inget slutdatum. Den kan börja med en provanställning på högst sex månader. Vill arbetsgivaren avsluta den under provtiden ska du få besked minst två veckor i förväg; annars blir den en vanlig tillsvidareanställning när provtiden är slut. Därefter krävs sakliga skäl för att säga upp dig, och uppsägningstiden är minst en månad, längre ju längre du har varit anställd.
Ett kollektivavtal kan ge andra regler än lagen.
Texten är skriven med AI och kan innehålla fel. Kontrollera med arbetsgivaren.
Källa: Lagen om anställningsskydd (LAS)
Arbetsgivaren
RaySearch har annonserat 38 jobb det senaste året: 35 tillsvidareanställningar och 3 tidsbegränsade anställningar. Inom yrkesgruppen Farmakologer och biomedicinare har de annonserat 3 gånger de senaste två åren, den här annonsen inräknad.
Källa: vår sammanställning av Arbetsförmedlingens annonser
Regulatory Affairs Support Specialist
RaySearch develops innovative software solutions to improve cancer care. Over 1200 clinics in more than 54 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, Asia and Australia & New Zealand. Today we are more than 485 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.
As a Regulatory Affairs Support Specialist, you will join our Quality Assurance and Regulatory Affairs team of dedicated specialists working to ensure compliance with global medical device regulations and to bring innovative cancer treatment solutions to patients worldwide.
About the role
In this role, you will take ownership of RaySearch's regulatory vigilance activities and work closely with colleagues across Quality Assurance, Regulatory Affairs, Service, Development. You will be responsible for assessing, reporting and following up on vigilance cases, while also supporting regulatory submissions and registrations in global markets.
This is an excellent opportunity for someone with a few years of experience in medical device regulatory affairs who wants to deepen their expertise in vigilance and continue developing within global regulatory affairs.
The position is based at RaySearch's headquarters in Stockholm and reports to the Group Manager Regulatory.
Your main responsibilities:
- Own and coordinate regulatory vigilance activities
- Assess complaints and incidents for reportability under applicable regulations
- Prepare, submit and follow up vigilance reports with competent authorities and notified bodies
- Support post-market surveillance activities and regulatory compliance efforts
- Support regulatory submissions and registrations in global markets
- Maintain and update regulatory documentation and records
- Monitor changes in regulatory requirements
- Collaborate with internal stakeholders to ensure timely and compliant regulatory deliverables
- Contribute to the continuous improvement of regulatory processes and procedures
Your profile
You are a positive, motivated and collaborative person with a genuine interest in regulatory affairs and medical devices. You enjoy taking responsibility, working in a structured way and finding practical solutions to complex regulatory challenges.
You are eager to learn, develop your expertise and grow within regulatory affairs. You thrive in a team environment, communicate effectively with different stakeholders and are comfortable managing multiple activities simultaneously while maintaining attention to detail.
Skills and experience:
- University degree in Life Sciences, Engineering, Biomedical Engineering, or a related field
- 2 years of experience in regulatory affairs within the medical device industry
- Experience working with EU MDR requirements
- Experience working with ISO 13485
- Experience with vigilance, complaint handling, post-market surveillance or related regulatory activities
- Experience supporting regulatory submissions and registrations
- Strong written and verbal communication skills in English
- Ability to work independently and collaboratively in a cross-functional environment
- Strong organizational skills and attention to detail
Merits:
- Software as a medical device (SaMD)
- Global regulatory submissions
- FDA regulations and international regulatory frameworks
- Radiation oncology
Our Offer
We offer a dynamic and inclusive work environment in Hagastaden, Stockholm's Life Science Hub. Our modern office space includes an in-house gym, yoga classes, and social activities such as after-work events. We also provide a fantastic lunch buffet, daily fika, and a stunning rooftop terrace with a 360-degree view of Stockholm. This comes with a competitive compensation and benefits package.
Application
Please apply for the position through the application form below. We do not accept applications via e-mail.
Avsnitt som inte handlar om jobbet är utelämnade. Hela annonsen finns hos Arbetsförmedlingen.
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