Medical Device Lead Auditor

Job Title: Medical Device Auditor
Location: Remote, UK Based
Travel: Will be required

Our client is looking for a Medical Device Auditor to plan and conduct professional management system audits in accordance with the company’s procedures.

Key Responsibilities:

1. Conduct audits at client sites or remotely to meet regulatory and stakeholder requirements.
2. Complete all chargeable work within budget and timelines to ensure customer satisfaction.
3. Manage specific projects related to medical device procedures, systems, and documentation.
4. Provide accurate and timely reporting for planning and operational management.
5. Oversee auditing teams to enhance client satisfaction and ensure compliance.
6. Manage personal schedule to meet chargeability targets.
7. Provide technical support and training to staff both in the UK and internationally.
8. Support business development efforts, including sales visits and event participation.
9. Conduct internal audits to ensure compliance with standards.
10. Maintain and update personal training records and certifications.

Qualifications & Experience:

Essential:

1. Proven experience in the healthcare or medical device industry, with experience in quality management.
2. Strong knowledge of medical device regulations: EU MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, UK MDR 2002, ISO 13485, MDSAP.
3. Experience in regulatory affairs, quality management, or clinical evaluations.
4. Competent in using MS Office and large databases.
5. Full UK driving license.
6. University degree or equivalent in relevant sciences (e.g., Medicine, Pharmacy, Biochemistry, Biomedical Engineering).

Desirable:

1. Registered IRCA lead auditor or similar certification.
2. Experience in reviewing technical documentation and audit packs.