Regulatory Affairs Specialist (SaMD)

Location:

Amsterdam – Noord-Holland, Nederland, Netherlands

Salary:

€60000 – €80000 per annum

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

133341427

Posted On: 

28 August 2026

Our client, a fast x2011;growing, innovation x2011;driven medical software company, is looking for a Regulatory Affairs Specialist to strengthen the team in Amsterdam.

In this senior role, you operate in a high x2011;tech SaMD environment where RA is truly broad: you’ll own multi x2011;region regulatory strategy (EU MDR, TGA, Canada, FDA support), and help define the future RA roadmap of a globally scaling digital health product.

Benefits:

* Tangible impact on patient lives by safeguarding global market access for a cutting x2011;edge AI tool.
* Strategic, senior international scope, building a broad regulatory footprint across EU MDR, TGA (Australia), Canada and FDA (supporting US colleagues).
* High x2011;tech SaMD environment with flexibility, working from the Netherlands with approximately 3 office days per week and room to tailor the setup for strong candidates.

Role Responsibilities:

* Develop regulatory strategies aligned with business objectives
* Lead submissions, documentation and lifecycle management, including technical documentation, registrations, audits (ISO 13485 and ISO 27001) and change control
* Act as the central RA expert for cross x2011;functional and international teams, advising R&D, Clinical, Quality and commercial colleagues
* Manage potential reportable events in collaboration with the medical team (Vigilance)
* Serve as the primary contact for local authorities and external regulatory bodies

Requirements:

* Degree in Science or Engineering or equivalent by experience
* At least 5 years of Regulatory Affairs experience within the medical device industry
* Experience with medical software / SaMD
* Proven multi x2011;region regulatory track record (EU MDR, FDA, Australia,…)
* Fluent in English

If this job appeals to you please apply here or send your CV to me, Annelies De Baere, on the NonStop Consulting website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.

About NonStop: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We’re passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting (nonstopconsulting), for more information, to browse all our roles, or to let us know how we can help you.

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