Senior Regulatory Affairs Officer - Glasgow
A Medical Device manufacturer in Scotland are on the lookout for a Senior Regulatory Officer to come in and ensure 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 projects within the business. This is a permanent position with the opportunity to be based remotely with occasional trips on site. The successful candidate will need experience working within the Medical Device industry and be eligible to work and based in the UK.
- Will deputise for the RA Manager in their absence.
- 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 IFU's, packaging and labelling materials and marketing literature
- Identification of National and International Standards and Regulations which apply to the Company's operations and implementation of new/changed standards and regulations.
- Maintain Technical files in compliance with current and changing regulations
Relevant Experience Required
- Proven experience of working in a similar regulatory role
- Knowledge of regulatory standards and global regulations for medical devices
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales