Job Title: Quality & Regulatory Affairs Specialist (QA/RA Specialist)
Location: Remote, EU citizenship required (European time zones a must)
Role Description:
Join a fast-growing MedTech startup on a mission to make medical device compliance faster and easier. As a Quality & Regulatory Affairs Specialist, you’ll work hands-on to prepare regulatory submissions, create quality and technical documentation, support clients, and contribute to the development of innovative AI-powered compliance tools.
Sector: Medical Devices, MedTech, AI-driven Regulatory Solutions
Must-Have Skills and Experience:
* Bachelor’s degree in Engineering, Life Sciences, or related field
* 2–4 years’ experience in regulatory or clinical affairs within medical devices
* Hands-on experience preparing technical documentation for EU regulatory submissions
* Solid knowledge of EU MDR (2017/745) and medical device standards (ISO 13485, ISO 14971, IEC 62304)
* Strong client-facing and communication skills
* Ability to work in a fast-paced, dynamic environment (startup experience preferred)
* Collaborate with cross-functional teams including engineering and product development
* Monitor global regulatory changes and adapt processes accordingly
Desirable Skills and Experience:
* Familiarity with US FDA regulations, 510(k), PMA, De Novo, and Q-Submissions
* Experience with Software as a Medical Device (SaMD) and hardware devices
* Knowledge of broader quality systems (CAPA, post-market surveillance)
* Experience with AI tools or prompt engineering with LLMs
* Familiarity with Notified Body conformity assessments and audits
What We Offer:
* Fully remote work with flexible hours
* Opportunity to work at the forefront of MedTech and AI compliance innovation
How to Apply:
Apply directly on LinkedIn. Interviews are moving fast and can be scheduled within a week, so early applications are strongly encouraged.
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