Global Regulatory Affairs Manager - Lead & Develop Team

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 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.