Quality Assurance and Regulatory Specialist
hace 1 semana
Job Summary
McR International is seeking a highly skilled Quality Assurance and Regulatory Affairs Specialist to join our team in Madrid. The successful candidate will be responsible for implementing a total quality culture within the company, ensuring compliance with MDR, ISO 13485, and 9001 requirements. This role will also involve maintenance and improvement of the Quality Management System (QMS), including SOP and WI development, as well as leading general regulatory audits and approval submissions.
Key Responsibilities
- Participate in the implementation of a total quality culture in the company, ensuring full compliance with MDR, ISO 13485, and 9001 requirements.
- Maintain and improve the Quality Management System (QMS), including SOP and WI development.
- Lead general regulatory audits and approval submissions.
- Drive internal and supplier audits.
- Coordinate and manage Management Meeting Review, including the maintenance of QA metrics (KPIs).
- Manage and monitor non-conformities and CAPAs.
- Manage QMS SW validations.
- Manage, design, and perform QA training.
- Support in the management of the Quality department budget.
- Support the Engineering and Manufacturing department in Quality and Regulatory Aspects of operations management.
- Manage Document Change Orders (DCOs).
- Manage suppliers' evaluation.
Regulatory Assurance
- Maintain the Regulatory Environment.
- Participate in the preliminary work for FDA, CE, and other medical approval processes in collaboration with agents, approval bodies, and consultants/CROs.
- Participate in the documentation for regulatory approval bodies and consultants.
- Coordinate Risk Assessment and Analysis throughout QMS and Product Development/Manufacturing.
- Support V&V activities.
- Support Clinical Investigations Submission to NCA and ECs.
Requirements
- Experience in the Healthcare Sector (> 3/5 years).
- Trainee experience in Quality Assurance, Quality Control.
- Thorough knowledge of ISO 13485:2016, ISO 9001:2015, and relevant Medical ISO standards, MDR, along US-FDA Regulations.
- Knowledge in GMP, GLP, GDP.
- Industrial Engineering, Science, or Medical Device Technology Degree.
- English (ALTE-4 or higher).
- Prior experience in the medical device industry.
- Certified Quality Auditor (preferably).
Reporting Line
Head of QA and VP Regulatory and Clinical Affairs
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