Accenian are representing a world leading healthcare manufacturer with a solid focus in drug delivery devices. The business require a Senior Regulatory Specialist to join the team on a permanent basis working closely with the QARA Director to help build and maintain their current processes.
What this position can offer you:
- Development into a management position with the autonomy to create your own regulatory team.
- The ability to travel within the EU, visiting other manufacturing sites to ensure compliance.
What’s involved in the role itself?
The company are looking to manufacture their own Medical Device and this position will see you heavily involved in bringing the product into the market place with a big focus on meeting MDR requirements throughout the process.
You will be working with customers to get the product CE marked and also looking to implement ISO 13485 across 2 sites.
Given the nature of this position, to be considered you must have relevant experience in the following:
- Supported both internal and external audits (FDA or MHRA)
- Minimum of 5 years working in a Regulatory position
- Confident in product approval process and creation of technical documentation
- Regulatory management of customer complaints and CAPA Management
If this role seems suited to you, please get in touch and we can explore further
Corrective And Preventive Action (Capa)
Medicines And Healthcare Products Regulatory Agency (Mhra) Guides
Medical Device Reporting