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.

Competencies :

• 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.

Please share your CV at [email protected] if you are interested in hearing more about the position.

As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.

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