Regulatory Affairs Support Specialist

About this job

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 Culture At RaySearch, we share a passion for innovation and the fight against cancer. Our team consists of dedicated experts who strive to deliver exceptional results through collaboration, attention to detail, and cutting-edge technology. We take pride in our role as a leader in cancer treatment, developing solutions that truly make a difference for patients worldwide. 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.

Want to know if you're a fit? Check your CV against this role — free, in 30 seconds.

Most-requested skills in Sweden

Based on 524 Sweden vacancies that list requirements, these are the skills employers ask for most often.

• Communication76% of postings
• CRM23% of postings
• English13% of postings
• Troubleshooting11% of postings
• SLA5% of postings
• Live Chat4% of postings
• Salesforce4% of postings
• Zendesk2% of postings

Similar jobs

• Application Support Specialist till Heras · Bravura Sverige AB
• Supporttekniker 1st line sökes! · Perido AB
• Junior projektledare – Change Management & Support · Sway Sourcing Sweden Aktiebolag
• Kundservicemedarbetare vid behov! · Veterankraft AB
• Kundservicehandläggare- längre visstidsanställning · Falck Sverige AB
• Customer Care & Sales Representative till Forenom · Bergvik & Partners AB