Clinical Auditor - Medical Device - Spain

Job Opportunity: Senior Lead Auditor - Medical Devices (IVDR Specialization)

We are currently offering an exciting opportunity for a seasoned Lead Auditor specializing in the EU In Vitro Diagnostic Medical Device Regulation (IVDR) to join our team in the Spain Affiliate.

This senior position is ideal for candidates with prior experience as a Lead Auditor within an IVDR Notified Body.

Key Responsibilities

1. Conduct audits at clients' sites, adhering to established procedures and delivering high-quality service to maintain strong customer relationships.
2. Work independently or lead audit teams as required, ensuring client satisfaction and compliance with regulatory standards.
3. Complete chargeable work within budget and timelines to enhance customer satisfaction and operational efficiency.
4. Undertake specific projects related to medical device procedures, processes, systems, and documentation, as directed by the Medical Devices Manager.

Qualifications

To apply, please submit your CV in English.

Essential Requirements:

1. Proven auditing experience within an IVD or IVDR Notified Body.
2. A minimum of 4 years of hands-on professional experience in designing, manufacturing, or testing IVDs.
3. At least 2 years of experience in quality assurance/management within a structured quality management system.
4. A university degree or equivalent qualification in a relevant science field, such as Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biomedical Engineering, Mechanical Engineering, Electrical or Electronic Engineering, or Computer & Software Technology.

Knowledge of:

1. EU IVDR 2017/746.
2. Standards and guidance documents relevant to in-vitro diagnostic medical devices.

Additional Attributes:

1. Proven ability to work independently and effectively manage and prioritize workloads.
2. Strong written and verbal communication skills in English.

Desirable but Not Essential:

1. Knowledge of or experience with other regulatory schemes and standards relevant to medical devices, such as IVDD, MDD, MDR, ISO 13485, or MDSAP.
2. Work experience with medical devices other than IVDs.
3. Registered IRCA Lead Auditor or equivalent certification under a recognized body.