Regulatory Affairs Specialist
Regulatory Affairs Specialist - Engineering
Medical Devices, Ostomy
Our client is a global manufacturer of medical devices. They are hiring a Regulatory Affairs specialist within the engineering function due to rapid growth. The role requires the chosen regulatory affairs candidate to operate as a regulatory resource for Engineering. The primary responsibilities of the position are to ensure regulatory compliance of defined products globally, drive regulatory processes and activities (such as change control) and continue to develop working relationships with internal and external customers. The chosen regulatory affairs candidate will be responsible for the management of global and regional regulatory projects, including, but not exclusively, product life cycle and regulatory processes within the engineering function.
- Creation, development and maintenance of high quality regulatory compliant documentation, especially for Class II/Unclassified products for the US market.
- For medical device products under development liaise with Project Development teams to ensure regional Regulatory Affairs requirements are included in the project plan and prepare the pre-marketing documentation for CE marking and 510k
- Build relationships and negotiate with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development
- Assist with global regulatory processes, such as Change Control, GMDN etc.
- Internal - Marketing, Operations, Regional Regulatory Affairs, R&D, Quality, Clinical
- External - Competent Authorities, Notified Bodies, other international governmental agencies
- Regulatory/Quality experience in medical devices.
- Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA
- Hands on experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
- Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971
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