Quality Assurance and Regulatory Affairs Manager

A London based Start-up Medical Device company developing a Class 1 Measuring Device is on the look out for a Regulatory Affairs Manager to support their growing business.
They are looking for an individual that is hard working and self motivated to assist with all things regulatory.
Responsibilities will include :
+ Oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
+ Working with Notified Bodies, taking the product through to FDA and FDR approval.
+ Provide regulatory guidance and support, ensuring compliance with EU regulations, and assist in third-party audits.
+ Develop and implement EU regulatory strategies, ensuring products meet all necessary requirements.
+ Manage project assignments for investigational, new, and marketed products.
+ Liaise with government agencies and gather regulatory intelligence.

+ More than 7 years' experience in regulatory affairs, ideally gained within a Medical device business.
+ Expert knowledge of MDR, ISO13485, UK MDR.
+ Experience interacting with Notified / Approved Body.
+ Ideally experince within orthopedics or surgical devices.

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