Regulatory Affairs Engineer — Post-Market Lead

Neko Health AB; Stockholms kommun; On-site; SEK 850,000 - 1,100,000; Full time

Benefits offered by this job

Competitive salary and benefits

Job summary

Neko Health AB is seeking a Regulatory Affairs Engineer to strengthen post-market surveillance across its device portfolio. You will operate the PMS system, ensure consistency, and drive improvements in a growing line of products.

The role also involves drafting regulatory documentation, supporting Notified Bodies, and collaborating with engineering, quality and clinical teams. Fluency in English and MDR experience are essential; we offer a supportive team and competitive package.

Qualifications

• At least 3 years in regulatory affairs or quality for medical devices, with post‑market focus.
• Experience with MDR, MDCG guidance, ISO 13485, and ISO 14971.
• Ability to develop repeatable PMS processes and reports.
• Strong analytical and writing skills, audit-ready output.
• Fluent in English, comfortable with AI tools for drafting and efficiency.

Responsibilities

• Run and maintain post-market surveillance across the device portfolio.
• Implement and update PMS SOP, keep current as the portfolio grows.
• Produce periodic post-market trend reports and literature searches.
• Prepare PMS sections of technical documentation and Notified Body reports.
• Support regulatory owners for post-market questions and cross‑programme alignment.

Skills

Regulatory affairs

Post-market surveillance

MDR experience

Notified Bodies

ISO 13485

ISO 14971

MDCG guidance

English (fluent)

AI tools Claude

VS Code

Azure DevOps

Education

BSc/MSc in engineering or life science

Job description

Neko Health AB is seeking a Regulatory Affairs Engineer to strengthen post-market surveillance across its device portfolio. You will operate the PMS system, ensure consistency, and drive improvements in a growing line of products.

The role also involves drafting regulatory documentation, supporting Notified Bodies, and collaborating with engineering, quality and clinical teams. Fluency in English and MDR experience are essential; we offer a supportive team and competitive package.