Lead Auditor MDR/IVDR – Medical Device Compliance

DNV Germany Holding GmbH; United Kingdom; Hybrid; GBP 61,000 - 75,000; Full time

Job summary

A leading assurance company is seeking a Team Lead Auditing MDR/IVDR in Hamburg, Germany. The role involves managing a team of Auditors to ensure accurate audit documentation and compliance with medical regulations. Candidates should have an academic degree in a relevant field and over 5 years experience in the Medical Device industry. Excellent leadership and communication skills are essential. This position supports both personal development and corporate growth in a prestigious technological environment, offering competitive compensation and benefits.

Benefits

Competitive compensation and benefit package

DNV training and qualification program

Professional community in a prestigious technological company

Access to an extensive competence network

Qualifications

• 5+ years work experience in the regulatory environment of ISO 13485, MDR, IVDR or MDSAP.
• Excellent knowledge of the Medical Device industry.
• Ability to represent the company by participating in internal audits.

Responsibilities

• Lead the Audit team to ensure accurate Audit Assessments.
• Responsible for developing the IVDR business strategy.
• Conduct assessments in accordance with relevant medical regulations.

Skills

Excellent communication

Leadership skills

Analytical skills

Fluency in German

Fluency in English

Education

Academic degree in Medical Technology, Engineering or Natural Science

Job description

A leading assurance company is seeking a Team Lead Auditing MDR/IVDR in Hamburg, Germany. The role involves managing a team of Auditors to ensure accurate audit documentation and compliance with medical regulations. Candidates should have an academic degree in a relevant field and over 5 years experience in the Medical Device industry. Excellent leadership and communication skills are essential. This position supports both personal development and corporate growth in a prestigious technological environment, offering competitive compensation and benefits.