A leading pharmaceutical manufacturer has an exciting opportunity for a Regulatory Affairs Officer to join its Medical Device division. As regulatory officer you will be responsible for the on-going maintenance and new dossier compilation of medical device products. To be considered you will have previous experience working in a regulatory function with medical device products.
1. Co-ordination and preparation of necessary documentation and reports for Medical Device technical files, and operation of the file review and maintenance system.
2. Compliance activities for the Medical Device products.
3. Regulatory participation in Medical Device Project work and Notified Body audits when necessary.
4. To support QA, helping to ensure that our ISO 13485 accreditation is maintained.
5. To maintain a knowledge and familiarity with current regulatory requirements for all aspects of the job.
6. To support the Regulatory Team Leader in the reporting and analysis of the departmental performance.
7. To attend as required appropriate industry regulatory meetings, such as the MHRA, PAGB or BSI.
• Degree in Life Sciences or equivalent.
• Prior experience within a regulatory function covering Medical Devices. Working knowledge ISO 13485 regulations.
• Proficiency in MS Word, Excel, and PowerPoint etc. would be preferred.
• Good attention to detail
• Excellent communication skills
• Analytical and numeracy skills
This is a fantastic opportunity to joining a leading company in the pharmaceutical industry.
Benefits: flexi- time, a good working environment, above statutory pension, a subsided canteen and 24 holidays plus statutory per annum.
Job Ref: 5447