Regulatory Affairs Officer
Lorne Laboratories Ltd, Reading
Salary: negotiable depending on experience - excellent rate of pay can be expected
Hours: 21 hours per week
Lorne Laboratories Ltd is a manufacturer of blood grouping reagents. The company employs 17 people and sells its products to over 90 countries worldwide.
Lorne is based in Reading near the M4 motorway, within easy commuting distance from all major cities in the south of England.
We have an exciting opportunity for an experienced Regulatory Affairs officer.
Reporting to the Technical Director you will be responsible for:
1. Ensuring that all procedures at Lorne comply with the IVD Directive, GMP, ISO 13485 and any other applicable standards.
2. Running the QMS system.
3. Preparing and carrying out of internal audits at Lorne.
4. Preparing and assisting with Third Party audits.
5. Attending BIVDA and other external Regulatory Affairs meetings.
6. Compiling and updating of Technical Files (STED’s) of Lorne products.
7. Carrying out and documenting risk assessments of Lorne’s reagents.
8. Helping to create Standard Operating Procedures.
9. Conducting post market surveillance of Lorne’s reagents.
10. Making sure that current national and international standards are in use at Lorne.
Knowledge and experience required for the post:
1. Strong working knowledge of the IVD Directive, GMP and ISO 13485.
2. Qualified and experienced internal auditor.
3. Excellent organisational skills.
4. Computer skills - Word Processing, Excel spreadsheets.
How to apply:
E-mail your CV to Eddy Velthuis, Technical Director at email@example.com or phone 0118-921 2264 for more information.