Regulatory Affairs Manager
Regulatory Affairs Manager (Contract)
Remote | Long term project
I'm currently working with a team developing an innovative product at the intersection of medical devices and pharmaceuticals. As part of their forward planning, they're looking to engage an experienced Regulatory Affairs Manager to support an upcoming programme.
The project focuses on a combination product with a novel delivery mechanism, offering the opportunity to get involved at an early stage and play a key role across both product development and long term regulatory strategy. This is a unique chance to help shape the direction of a product as it moves towards market readiness.
Key areas of focus:
- Supporting EU regulatory compliance, including MDR considerations
- Contributing to regulatory strategy and submission planning
- Working closely with cross functional product teams to ensure readiness
- Supporting the development of processes and documentation frameworks
- Playing a role in early product validation and market alignment
There's a strong emphasis on early regulatory positioning, with a clear roadmap towards full compliance as the product matures and progresses through its lifecycle.
What they're looking for:
- Proven Regulatory Affairs experience within medical devices or combination products
- Strong understanding of EU regulations and regulatory pathways
- Experience supporting submissions and broader regulatory strategy
- Ability to operate effectively in evolving or early stage environments
- Comfortable working cross functionally within a dynamic project setting