Job Description

208254609
£36 - £38/hour
13-Jul-2018
 

Regulatory Affairs Specialist

If you’re an existing Regulatory Affairs professional looking for a challenging new opportunity, it would be great to talk to you about a new role I’m handling.I’m working with a leading UK Pharmaceutical company looking to recruit a Regulatory Affairs Specialist.You will be responsible for providing Regulatory leadership for global regulatory affairs.As well as having a body of Regulatory Affairs experience you will also have experience with Medical devices.Examples of the work involved areTo stay current on new product development and change projects and determine global filing strategies.Partner with in-country regulatory affiliates to understand registration requirements for new product registration and lifecycle license maintenance (change registration, renewals) for existing products.Consolidate global regulatory feedback and communicate requirements to change owners/project leads.Provide documentation and product support to in-country regulatory affiliates for registration filings.Assists in the development of best practices for Regulatory Affairs processesReviews and approves product labelling as requiredProvides support for other regulatory activities as requiredTo be considered for the position you must have-* Regulatory Affairs experience within the medical device industry with knowledge of IVD
* Experience with global regulatory requirements and filings desired
* Demonstrated understanding of Design Control
* Degree qualified, preferably in a scientific fieldIf the role sounds interesting and you’d like an informal, non-committal conversation please get in touch.(Apply online only)Established in 2002 Blue Pelican is a REC accredited recruitment business providing interim and permanent solutions to life science clients on a pan European basis