Team Lead Auditing MDR/IVDR

DNV; Hamburg; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading certification body in Hamburg is seeking a Team Lead Auditing MDR/IVDR to oversee Auditors and Experts. This pivotal role entails ensuring accurate assessments, developing business strategies, and enhancing compliance standards. Candidates should possess a strong background in the Medical Device sector, regulatory experience, and excellent communication skills in both German and English. Competitive compensation and professional training programs are offered.

Leistungen

Competitive compensation and benefits package

DNV training and qualification programs

Access to a professional community

Opportunities for challenging projects

Access to an extensive competence network

Qualifikationen

• 5+ years of experience in the regulatory environment of ISO 13485, MDR, IVDR, or MDSAP.
• Strong knowledge of the Medical Device industry, preferably with experience in both Notified Bodies and Industry/Manufacturing/Pharmaceutical companies.
• Ability to represent the company in internal audits with accreditation bodies.

Aufgaben

• Lead the Audit team to ensure complete and accurate assessments.
• Develop the IVDR business and support recruitment.
• Conduct assessments in accordance with MDR and IVDR standards.

Kenntnisse

Leadership skills

Analytical skills

Communication skills

Project management

Fluency in German and English

Ausbildung

Academic degree in Medical Technology, Engineering, or Natural Science

Jobbeschreibung

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Team Lead Auditing MDR/IVDR at DNV MEDCERT

We are seeking a Team Lead Auditing MDR/IVDR to join DNV MEDCERT in Hamburg, Germany. The Team Lead will oversee a team of Auditors and Experts, ensuring the delivery of assessment and certification services that meet customer requirements and accreditation standards. This role is crucial for leading and developing the Audit group and fostering organizational growth in the IVDR sector.

Responsibilities:

1. Lead the Audit team (Auditors and Experts) to ensure complete, accurate, and timely Audit and Technical Documentation Assessments.
2. Develop the IVDR business, implement business strategies, and support recruitment and development within this area.
3. Establish close internal collaboration with the IVDR team of DNV Product Assurance AS.
4. Manage teams to improve efficiency, increase customer satisfaction, and ensure compliance with standards.
5. Conduct assessments in accordance with MDR 2017/745 or IVDR 2017/746.
6. Perform audits under EN ISO 13485, MDR 2017/745, IVDR 2017/746, and MDSAP.
7. Report to the Head of Auditing and Experts.

Benefits:

• A competitive compensation and benefits package
• DNV training and qualification programs
• Access to a professional community within a prestigious technological company
• Opportunities to work on interesting and challenging projects
• Access to an extensive competence network

Qualifications:

• An academic degree in Medical Technology, Engineering, or Natural Science
• 5+ years of experience in the regulatory environment of ISO 13485, MDR, IVDR, or MDSAP
• Strong knowledge of the Medical Device industry, preferably with experience in both Notified Bodies and Industry/Manufacturing/Pharmaceutical companies
• Ability to represent the company in internal audits with accreditation bodies
• Proficiency in analytical data to monitor and drive performance
• Excellent communication, presentation, and leadership skills, with the ability to interpret complex information
• A forward-thinking mindset and understanding of the Notified Body environment
• A pragmatic working style, understanding the big picture while paying attention to details
• Fluent in German and English, with strong written and verbal communication skills

Please note that we require the following documents to proceed with the interview process: Curriculum Vitae (CV), Cover/Motivation Letter, University Diplomas & Transcripts, Reference Letters. All documents should preferably be in English. Kindly submit them at your earliest convenience to facilitate a smooth and timely assessment. Thank you for your cooperation.