Global Regulatory Affairs Leader – Submissions & Compliance

Raysearch Laboratories AB (Publ); Solna kommun; On-site; SEK 900,000 - 1,300,000; Full time

Benefits offered by this job

In-house gym

Yoga sessions

Social activities and events

Lunch buffet

Job summary

RaySearch Laboratories AB (Publ) is seeking an experienced Regulatory Affairs Manager to lead a team of 5 Regulatory Affairs Specialists. You will guide global regulatory submissions, registrations, vigilance, and post‑market activities while driving process improvements and regulatory excellence across the organization.

The role requires strategic yet hands‑on leadership, strong cross‑functional collaboration, and a proven track record in the medical device regulatory landscape, including EU

Qualifications

• Extensive Regulatory Affairs leadership in medical devices.
• Proven experience managing regulatory professionals and building high‑performing teams.
• Deep expertise in EU MDR and global submissions.

Responsibilities

• Lead a team of 5 Regulatory Affairs Specialists across global activities.
• Oversee regulatory submissions, registrations, vigilance, and post‑market activities.
• Drive regulatory process improvements and cross‑functional collaboration.

Skills

Regulatory leadership

Regulatory affairs

EU MDR

Global submissions

People management

IEC 62304

ISO 13485

ISO 14971

English proficiency

Job description

RaySearch Laboratories AB (Publ) is seeking an experienced Regulatory Affairs Manager to lead a team of 5 Regulatory Affairs Specialists. You will guide global regulatory submissions, registrations, vigilance, and post‑market activities while driving process improvements and regulatory excellence across the organization.

The role requires strategic yet hands‑on leadership, strong cross‑functional collaboration, and a proven track record in the medical device regulatory landscape, including EU