Medical Device Compliance Engineer
About this role
This will help you grow:
- Ensure compliance with EU MDR (2017/745) and IVDR (2017/746).
- Support regulatory strategies and submissions for EU and global markets.
- Perform product classification and regulatory gap assessments.
- Prepare and review technical documentation (Annex II & III, GSPR, traceability matrices).
- Develop Design Dossiers and manage document lifecycles.
- Support Clinical Evaluation Reports (CER), PMS, PMCF, and vigilance reporting.
- Ensure ISO 13485 compliance and support audits, CAPA, and change control.
- Support EUDAMED registrations and UDI requirements.
- Contribute to MDR/IVDR transition projects, audit readiness, and product lifecycle activities.
This is how you will help us move forward:
- 5–10 years’ experience in medical device regulatory affairs.
- Strong knowledge of EU MDR/IVDR requirements.
- Hands-on experience in technical documentation and clinical evaluation.
- Understanding of ISO 13485 and exposure to ISO 14971 preferred.
- Bachelor’s degree in Biomedical, Life Sciences, Pharmacy, or related field.
- Strong analytical, documentation, and communication skills.
- Exposure to US FDA or global registrations is an advantage.
Company at a glance
About the EDAG Group
The EDAG Group is a globally leading, independent engineering service provider with experts in mobility, defense, industry, and public solutions. The company combines engineering excellence with the latest technological trends and provides comprehensive support to clients in the development of complex products, systems, and production solutions in an increasingly interconnected environment.
With an interdisciplinary team of some 8,000 experts, a global network of around 70 locations, and over 55 years of engineering experience, the EDAG Group pursues a unique 360-degree development approach that encompasses modern mobility solutions as well as industrial applications, safety-critical systems, and complex development and transformation projects for the public sector.
Across industries, the EDAG Group develops products, production facilities, and plants that holistically integrate and digitally connect all manufacturing-related processes. Innovative strategies, data-driven development approaches, and a powerful digital infrastructure form the foundation for forward-looking solutions — from highly automated industrial environments and resilient defense systems to sustainable concepts for public sector clients. The interdisciplinary approach and a strong partner network enable an optimal customer experience for an international client base comprising leading companies, institutions, and public sector clients.
The company has been listed on the stock exchange since 2015 and generated sales of € 714 million in 2025.
For more information, see the EDAG Group website: www.edag.com
Tired of cold applications?
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Know someone who'd be great for this?