Regulatory Affairs Engineer, Post-Market Surveillance
Hybrid (Stockholm)Full-timePosted 4w ago
About the role
Regulatory affairs engineer to strengthen post-market surveillance across Neko's device portfolio, with autonomy to shape processes and contribute to regulatory activities throughout the device lifecycle.
Responsibilities
- Run and maintain the post-market surveillance process across the device portfolio, applying it consistently from programme to programme.
- Put the PMS SOP into practice, keep it current, and propose updates as the process matures.
- Produce the periodic post-market trend reporting and the post-market literature searches, and establish a repeatable method for both.
- Prepare the post-market sections of technical documentation and the periodic reports delivered to Notified Bodies.
- Support the regulatory owners of individual devices on post-market questions, and become the reliable point of contact for PMS across programmes.
Qualifications
- BSc or MSc in engineering, medicine, pharmacy, law or another relevant scientific discipline, or equivalent professional experience
- At least 3 years in regulatory affairs or quality for medical devices, with a meaningful part of that time spent on post-market activities (three to five years is the target)
- Medical device experience, with familiarity in MDCG guidances and post-market obligations specific to medical devices
- Working knowledge of EU Regulation 2017/745 (MDR) post-market requirements, applicable MDCG guidances, ISO 13485, and ISO 14971
- Experience contributing to periodic post-market reporting for a Notified Body
- Excellent analytical and writing skills
- Self-motivated and able to run a cross-programme workstream efficiently
- Fluent in English (oral and written)
- Comfortable using AI tools such as Claude for research, drafting, and operational efficiency
- Experience automating or streamlining regulatory workflows, including light scripting (advantageous)
- Experience with Visual Studio Code and Azure DevOps (advantageous)
Skills
Required:Post-market surveillance (PMS)Regulatory submissions and Notified Body interactionsRegulatory strategy and lifecycle managementDocumentation writing and analysis
Benefits
- Competitive salary and benefits package
Last updated Oct 23, 2026. Interested? Apply on the company site.
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