Regulatory Affairs Support Specialist

RaySearch Laboratories; Stockholms kommun; Vor Ort; SEK 550.000 - 750.000; Vollzeit

Benefits dieser Stelle

In-house gym

Yoga classes

Social events

Lunch buffet

Daily fika

Rooftop terrace

Competitive compensation

Zusammenfassung

RaySearch Laboratories in Stockholm is seeking a Regulatory Affairs Support Specialist to own vigilance activities and back regulatory submissions for global markets.

You will collaborate across QA and Regulatory Affairs, Service and Development, ensuring compliant post‑market surveillance and timely regulatory deliverables.

The role suits a few years of medical device regulatory experience, with EU MDR and ISO 13485 familiarity, and strong English communication.

Qualifikationen

• You have a university degree in Life Sciences, Engineering, Biomedical Engineering or a related field.
• You have 2 years of experience in regulatory affairs within the medical device industry.
• You have experience with EU MDR requirements and ISO 13485.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Vigilance

Post-market surveillance

Regulatory submissions

EU MDR

ISO 13485

English communication

Cross-functional collaboration

Attention to detail

Ausbildung

University degree in Life Sciences, Engineering, Biomedical Engineering

Jobbeschreibung

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.

• in-house gym
• yoga classes
• social activities such as after-work events
• fantastic lunch buffet
• daily fika
• stunning rooftop terrace with a 360-degree view of Stockholm
• competitive compensation and benefits package.