Industry: Medical Devices
Location: Sandy, Bedfordshire
A great opportunity has arisen for a Regulatory Affairs Manager for a leading Medical Device development company based in Bedfordshire. This company specialises in outstanding diagnostic solutions for the consumer healthcare industry.
As the Regulatory Affairs Manager you will be required to provide guidance and documentation for new R&D projects which will include participation in Design Control and Risk Management activities. You will need to have current working knowledge of ISO13485, EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC along with US FDA 21 CFR Parts 820.
Regulatory Affairs Manager Requirements:
* Widespread and current working knowledge of ISO 13485, EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC, and US FDA 21 CFR Parts 820
* Experience in Regulatory Submissions, specifically US 510(k) and EU CE Technical Files
* Full knowledge of working with IVD/Medical Device Post Market activities
* First rate communication skills
* Ability to plan and manage the Regulatory Product Lifecycle Teams workload
Regulatory Affairs Manager Responsibilities:
* Provide Regulatory leadership and documentation for new R&D Projects
* High quality Regulatory 510(k) and CE Technical File submissions
* Management of Regulatory Post-market activities
If you are interested in this Regulatory Affairs Manager opportunity, click Apply Now and we will be in touch with you.