Regulatory Affairs Specialist
- Type Permanent
- Location Meath, Republic of Ireland
- Sectors Regulatory Affairs (RA)
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