Senior Regulatory Affairs Specialist


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

28th August 2019

Location

Waterford

Salary/Rate

£46167 - £54561

Type

Permanent

Start Date

01/08/2019

This job has now expired please search on the home page to find live IT Jobs.

My client are a medical device organisation and are seeking to take on a Senior Regulatory Affairs Specialist on a permanent basis. They're located in Waterford and have a reputation for introducing and marketing innovative, high-quality products. They currently employ over 1000 people, and you could be the next to join them!What will I be doing as a Senior Regulatory Affairs Specialist?Support all aspects of the EU Authorised Representative function in Ireland for the companies products.Deputise for the Regulatory Affairs Manager for all regulatory body communications.Provide EU Regulatory subject matter support to team for key projects and activities.Serve as the person responsible for regulatory compliance for the EU Authorised Representative.Develop and maintain a good knowledge of the companies products.Verify the EU Declaration of Conformity, Technical Documentation and Conformity Assessment carried out by the legal manufacturer.Maintain the Authorised Representative registration with the Irish competent authority (HPRA) and maintain product registrations for Vision Care products.Submit Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN) in the EEA, Switzerland and candidate countries on behalf of the legal manufacturer.Field questions from competent authorities regarding product performance and/or vigilance and recall on the EU market.Work with the legal manufacturer to provide responses to questions from competent authorities.Participate in notified body and competent authority inspections of Vison Care legal manufacturer and manufacturing sites.Manage the process for provision of certificates of free sale for Vison Care to support maintenance of business and/or market expansion including authentication, apostille and embassy legalization.Upgrade the Authorised Representative policies, procedures and work instructions for EU MDR compliance.Provide advice regarding interpretation of MDD 93/42/EEC and MDR 2017/745 including associated guidance (e.g. Meddev, Common Specifications etc.).Support key EU MDR work streams (e.g. economic operators, technical files, quality systems).Contribute to discussions internally and with notified body and competent authorities.What do I need to be a Senior Regulatory Affairs Specialist ?Minimum bachelor's Degree BS in an engineering or scientific discipline or a Master's degree MS in regulatory affairs or a related discipline.4-5 years' experience in regulatory affairs. If this role sound like the next step for you and you have previously worked in Regulatory affairs apply with an up to date CV. To find out more about Real please visit www.realstaffing.comReal 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

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