Spain
REGULATORY AFFAIRS AND QUALITY ASSURANCE
Employer company:
INMET GARNICK
Industry:
Engineering & Manufacturing
Career level:
Mid-level
Employment type:
Full time
Job location:
Azuqueca De Henares, Guadalajara
Salary offered
1 001 to 2 500 EUR
Requirements
Education:
Bachelor's Degree
Experience:
2-5 years
Languages:
English, Spanish
Driving license:
No
Job role
Preferential values are:
- Certificate or diploma of training in ISO 13485
- Certificate or diploma of training in Risk Management ISO 14971
- Certificate or diploma of training in MDD
- Certificate or diploma of training in REGULATION (EU) 2017_ 745
- Certificate or diploma training in internal audits.
- Qualification in validation of IQ, OQ, PQ processes.
- Knowledge in microbiology.
- Language, high level of English and other languages will be valued.
- Dentist qualification is valued, not practicing.
- Good availability.
- Driving license B.
Description
-Maintenance of the Quality Management System in accordance with ISO 13485.
- Nonconformity Management: Opening, investigation and closure of CAPAs.
- Development and preparation of Internal Audit.
- Preparation and compliance with SOPs procedures for compliance with MDR
- Participation of external audits, under ISO13485 and CE marking.
- Monitoring of regulatory changes: monitoring of any mandatory regulations and their implementation in the system.
- Manage: notifications, updates and communication of the placing on the market of new products or range expansion, in AEMPS and ON
- Preparation of risk analysis in processes and product.
- Update of Clinical Evaluation reports
- Update and elaboration of risk analysis ISO 14971.
- Post-market surveillance: coordinate market withdrawals and management of product and service claims.
- User information control: Labeling, IFUS, Technical Sheet, certified product list, Check list.
- Preparation of Technical File and dossiers, used commercially, with complete product information, both at the regulatory level, of product specifications, properties of the same, applications and description of main assets through the search for scientific articles
- Maintaining identification and traceability of product (UDI).
- Maintenance and revalidation of internal and external production processes.
- Manage product quality assurance: claims, incidence, certificates of analysis, product release, microbiological and particle control, product stability control, manufacturing processes, external treatment certificate, sterility, etc.
- Collaborate with cross-functional teams for the development of new products
Benefits
Medical insurance
