Senior Regulatory Affairs Officer - Cumbernauld, United Kingdom - Isaac Gracie

Isaac Gracie

Verified Company

Cumbernauld, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

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Description

Senior Regulatory Affairs Officer

Salary - £45,000
Our client is an international aesthetics market leader, boasting over 30 years industry experience. Innovation and continuous improvement rank high as their key drivers when manufacturing the product portfolio. A fantastic opportunity has arisen for a Senior Regulatory Affairs Officer to join their Regulatory Affairs team.

This role within the Regulatory team is to support the Manager in ensuring compliance with regulations within Europe and globally, to register new and existing products with regulatory authorities to allow for growth of the business and to manage key regulatory projects within the business.

Key Responsibilities

Maintenance of Design Dossiers for Class IIa, IIb and III products.
Preparation of regulatory submissions for global product registrations
Leading key regulatory projects across the business
Development of regulatory strategies aligning with market and business objectives.
Provide input to content and compliance of IFUs, packaging and labelling materials and marketing literature
Will deputise for the RA manager in their absence.

Qualifications / Experience

Relevant science or engineering degree.
Proven experience of working in a similar regulatory role (preferred not essential)
Knowledge of regulatory standards and global regulations for medical devices.
Excellent facilitation, coordination, prioritization and communication skills.

Enjoy the flexibility of a hybrid role with time spent working from home and at their Cumbernauld office. A wide variety of interesting and challenging tasks. If your background is all things regulatory we would love to hear from you.

Salary:
Up to £45,000.00 per year

Ability to commute/relocate: