Regulatory Affairs Specialist

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I am currently working with a market leader in manufacturing and supply of medical devices,Who have an immediate opening for a Regulatory Affairs Specialist.The company are located in Meath.

This is a permanent position with great salary.

What will I being doing as a Regulatory Affairs Engineer?

* Generate and maintain technical files for CE Marked Products and all other relevant documentation required to comply with the Medical Device Directive 93/42/EEC and its relevant national transpositions and any other national or international regulations which apply to the company.

* FMEA execution and Risk management reports as per ISO 14971 as part of technical file updates.

* To correspond / communicate with auditing bodies and regulatory authorities in all relevant matters relating to the company.

* To promptly reply to customer and regulatory queries in relation to quality, technical and regulatory information for products manufactured & distributed by the company.

* To liaise with the relevant markets and update product registrations.

* Create and maintain Own Brand Labelling Files.

Quality Assurance Responsibilities:

* Execution of sterilisation report reviews.

* Execution of QA Batch reviews.

* Execution of product quality reviews.

* Internal Auditor actively participating in internal audits with the companies audit team.

* External Audit training in progress.

* QA Inspections as per Inspection schedule.

* Assist to ensure overall quality compliance.

* Performance of gap analysis to ensure compliance to Guidelines such as EU directives and EU GMP guidelines, Annexes and the company's Manufacturing Authorisation.

* Respond and execute field safety corrective actions when required.

* Analyse quality systems and processes for improvement.

* Assist in deviations, SCARs , complaints, non-conformance's.

* Update internal quality documentation.

* To liaise with the relevant component authorities and notified bodies of incidents and Field safety corrective action. Execution of field safety corrective actions.

* Assist with the overall compliance to the quality system.

* Assist in the analysis of quality systems with the intention of designing, promoting and implementing systems and processes for continuous improvement and customer satisfaction.

* Ensure the reporting of all quality activities is carried out accurately and in a timely fashion in keeping with the requirements of the management information system and S.O.P in place.

* Carry out projects and duties as assigned by your manager in an efficient, timely and cost effective manner.

What I need to be a Regulatory Affairs Engineer?

* Educated to degree or equivalent level in a Quality or Scientific discipline.

* Must have experience in a Quality Assurance or Microbiology role within a medical device company or Pharmaceutical field.

* Must have experience in regulatory affairs / regulations within a medical device company or Pharmaceutical field.

* Must have a flexible approach to work and be capable of handling multiple priorities in a fast paced environment.

* Strong attention to detail with a high degree of accuracy and excellent organisational and communication skills.

Don't miss out on a this opportunity to get great experience with an exciting company.

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