Company Description
Moroxite AB is developing a next-generation synthetic bone substitute for spinal fusion surgery. The technology is designed to improve bone healing while eliminating the need for bone harvesting from the patient’s own hip, reducing surgery time, complication risk, and the need for revision surgery.
The company’s technology combines a biodegradable 3D structure with a bone-stimulating protein to support natural bone regeneration and targeted healing. It is being developed for use across multiple spinal fusion procedures, including posterolateral fusion (PLF).
Job description
We are looking for an experienced Regulatory Affairs Manager to lead regulatory strategy and submissions for our medical device and combination products across the US and EU.
Key responsibilities
- Develop global regulatory strategies and lead submissions for medical devices and combination products, ensuring compliance with applicable requirements and readiness for electronic publishing.
- Manage product registrations and technical documentation throughout the product lifecycle
- Provide regulatory guidance to R&D, Clinical, and Manufacturing teams, including design controls, labeling, promotional claims, and clinical trial requirements
- Work closely with clinical teams on regulatory considerations for clinical trial design and clinical data generation
What we’re looking for
- 5–10 years’ experience in medical device and/or combination product Regulatory Affairs
- Strong knowledge of FDA regulations and EU MDR
- Proven experience preparing regulatory submissions and interacting with FDA and notified bodies
- Strong regulatory writing and technical documentation skills
- Ability to translate complex scientific, engineering, and clinical information into clear, audit-ready documentation
- Excellent communication, collaboration, and negotiation skills
- Master’s degree in life sciences, pharmacy, engineering, or a related field
Please apply here or send your CV to Marie Grey at marie.grey@moroxite.com.
