Team Lead Auditing MDR/IVDR

vor 22 Stunden

Hamburg, Hamburg, Deutschland DNV Vollzeit 600.000 € - 1.000.000 € pro Jahr
Description

We are looking for a Team Lead Auditing MDR/IVDR to join DNV MEDCERT in Hamburg, Germany. The Team Lead will manage a team of Auditors and Experts enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. The role is essential to lead and develop the Audit group and to enable organizational growth in the IVDR sector.

  • Leading the Audit team (Auditors and Experts) to ensure complete, accurate and timely Audit and Technical Documentation Assessments.
  • Responsible for the development of the IVDR business, implementation of the business strategy, as well as recruitment, development and support of additional resources within this area.
  • Establishing and developing close internal collaboration with the IVDR team of DNV Product Assurance AS.
  • Management of teams to improve efficiency, increase customer satisfaction and ensure compliance with standards.
  • Conduct assessments in accordance with MDR 2017/745 or IVDR 2017/746.
  • Conduct audits under EN ISO 13485, MDR 2017/745 or IVDR 2017/746, and MDSAP.
  • Responsible for reporting to Head of Auditing and Experts.
Responsibilities
  • A competitive compensation and benefit package
  • DNV training and qualification program
  • A professional community in a prestigious technological company
  • Possibilities to work with interesting and challenging projects
  • Access to an extensive competence network

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture, and we invite you to be part of this diversity.



Qualifications
  • An academic degree in Medical Technology, Engineering or Natural Science.
  • 5+ years work experience in the regulatory environment of ISO 13485, MDR, IVDR or MDSAP.
  • Excellent knowledge and understanding of the Medical Device industry, preferably with experience covering both Notified Body's and Industry / Manufacturing / Pharmaceutical companies.
  • Ability to represent the company by participating in internal audits with accreditation bodies.
  • Ability to use analytical data in order to monitor and drive performance excellence.
  • Excellent communication, presentation and leadership skills; ability to interpret and present highly complex and strategically significant information.
  • We hire for mindset Forward-thinking mindset and an understanding of the Notified Body environment.
  • A pragmatic working style: Understanding the big picture while being able to dive into the detail.
  • Written and verbal communication skills; fluent in German and English.

Please note that we cannot proceed to the interview stage without the following documents: Curriculum Vitae (CV); Cover- /Motivation Letter; University Diplomas & Transcripts; Reference Letter(s). All documents shall preferably be submitted in English. Please provide them at your earliest convenience to ensure a smooth and timely assessment process. Your cooperation in this matter is greatly appreciated.

Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.

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