Group Manager Regulatory Affairs - Global Medical Devices

RaySearch Laboratories AB (publ); Stockholms kommun; On-site; SEK 900,000 - 1,300,000; Full time

Benefits offered by this job

In-house gym

Lunch buffet

Rooftop terrace

Fika daily

Team events

Job summary

RaySearch Laboratories AB in Stockholm is seeking an experienced Regulatory Affairs Manager to lead a team of 5 Regulatory Affairs Specialists. You will drive global regulatory submissions, registrations and compliance across our medical device portfolio, and continuously improve regulatory processes.

We value pragmatic leadership, cross‑functional collaboration and a strong focus on developing talent while delivering regulatory excellence in a dynamic, international environment.

Qualifications

• Extensive Regulatory Affairs leadership experience in medical devices.
• Proven ability to lead, coach and develop regulatory professionals.
• Deep knowledge of EU MDR and global regulatory submissions.

Responsibilities

• Lead a team of Regulatory Affairs Specialists (5).
• Oversee resource planning across global regulatory activities.
• Ensure high-quality global submissions and product registrations.
• Own and improve core regulatory processes and ways of working.
• Support post‑market activities including vigilance and PSURs.

Skills

Regulatory leadership

Team development

Global regulatory submissions

EU MDR expertise

Regulatory intelligence

English proficiency

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.

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, with experience with at least one of the following regulatory authorities 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 optimise regulatory operations, improve processes and lead teams through organisational change.
• Excellent planning, prioritisation 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 cyber‑security requirements for medical devices.
• Experience with AI/ML‑enabled medical devices.

Our Culture

Culture at RaySearch is the driving force behind our organisation, 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.