Regulatory Lead - Medical Device Software

Raysearch Laboratories AB (Publ); Solna kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

RaySearch Laboratories AB is seeking an experienced Regulatory Lead to own the regulatory strategy and lifecycle oversight for a RaySearch product. You will be the main regulatory contact, partnering with Development, Corporate Strategy and Sales to shape strategy and drive market access.

This high-visibility role combines regulatory expertise with strategic thinking, project coordination, and collaboration across the organization in a fast-paced environment.

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• Several years of Regulatory Affairs experience within the medical device industry.
• Strong experience preparing and reviewing Technical Documentation under EU MDR.
• Experience working with medical device product development and design control processes.
• Experience with medical device software.
• Strong knowledge of IEC 62304, IEC 60601 and ISO 14971.
• Strong project management and stakeholder management skills.
• Proficiency in English.

Responsibilities

• Own and drive the global regulatory strategy for your product throughout its lifecycle.
• Lead the preparation, review, and maintenance of Technical Documentation and regulatory submissions, including EU MDR.
• Act as the regulatory expert within development projects and ensure regulatory requirements are integrated throughout the design and development process.
• Coordinate and oversee multiple projects, priorities, and submission timelines while maintaining a long‑term view of the product roadmap.
• Partner closely with Development, Corporate Strategy, Sales and other key stakeholders to support product development and market access.
• Support inspections, audits, post‑market activities, and continuous improvements.

Skills

Regulatory Affairs

Technical Documentation

Medical Device Software

IEC 62304

IEC 60601

ISO 14971

Project Management

Stakeholder Management

English Proficiency

Education

Bachelor's or Master's degree in Engineering/Life Sciences/Regulatory Affairs

Job description

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.

About the role

We are looking for an experienced and driven Regulatory Lead to own the regulatory strategy and lifecycle oversight for one of RaySearch's products. In this role, you will be the regulatory point of contact for the product, working closely with key stakeholders in the Development, Corporate Strategy and Sales teams. You will help shape product strategy, guide development activities, drive market access, and ensure compliance throughout the product lifecycle.

This is a highly visible role for someone who enjoys combining deep regulatory expertise with strategic thinking, project coordination, and collaboration across the organization.

What you'll do

• Own and drive the global regulatory strategy for your product throughout its lifecycle.
• Lead the preparation, review, and maintenance of Technical Documentation and regulatory submissions, including EU MDR.
• Act as the regulatory expert within development projects and ensure regulatory requirements are integrated throughout the design and development process.
• Coordinate and oversee multiple projects, priorities, and submission timelines while maintaining a long‑term view of the product roadmap.
• Partner closely with Development, Corporate Strategy, Sales and other key stakeholders to support product development and market access.
• Support inspections, audits, post‑market activities, and continuous improvements.

Your profile

You are a proactive and pragmatic regulatory professional who enjoys taking ownership and driving things forward. You are technically strong, comfortable working with development teams, and able to translate complex regulatory requirements into practical solutions.

You like having oversight of the full product picture—from early development and regulatory strategy to submission and post‑market activities—and you thrive in a collaborative, fast‑paced environment where you can make a real impact.

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• Several years of Regulatory Affairs experience within the medical device industry.
• Strong experience preparing and reviewing Technical Documentation under EU MDR.
• Experience working with medical device product development and design control processes.
• Experience with medical device software
• Strong knowledge of IEC 62304, IEC 60601 and ISO 14971
• Strong project management and stakeholder management skills.
• Ability to manage multiple activities and timelines while maintaining the bigger picture.
• 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 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.