Medical Device Technical Assessor or Lead Auditor (MDD / MDR)

Employment Type

: Full-Time


: Healthcare - Allied Health

Local Unit & Position Description

The market demand for certification of medical devices is growing and we are expanding our team of auditors and assessors in order to service customers globally. Presafe Denmark A/S is a notified body for certification of medical devices and in-vitro diagnostic medical devices. We offer companies CE marking of medical devices for sale on the European market, as well as certification of quality systems according to requirements of relevant quality standards.

Presafe Denmark A/S is part of the Presafe family headquartered in Oslo, Norway, and which is owned by DNV GL Business Assurance.

Originated in 1864, DNV GL operates globally in more than 100 countries with our 16,000 professionals dedicated to helping our customers make the world safer, smarter and greener.

As a world-leading certification body, we work with companies to assure the performance of their organisations, products, people, facilities and supply chains through certification, verification, assessment and training. As part of the larger DNV GL Group, our 2,000 Business Assurance employees worldwide help our customers build sustainable business performance and create stakeholder trust. We promise to be focused on your future.

For the position of Lead Auditor, your primary tasks will include:
Planning and conducting audits (internationally) with the aim of ensuring product and management system compliance
Ensuring that audits are conducted in a competent way and within requirements from authorities, leading to satisfied customers.

For the position of Assessor, your primary tasks will include:
Evaluation/assessment of technical documentation against regulation and standards, to ensure product compliance.
Interaction and consultation with relevant authorities and medical/technical experts in the approval process, as needed, and participation in audits (worldwide) with the aim of ensuring compliance of the product.

Position Qualifications

Your qualifications:
Bachelor or master within Pharmaceutical/Science/Engineering
A broad experience within the medical device sector: Minimum 5 years working experience in the medical device sector (medical device or pharmaceutical industry, relevant test laboratory, notified body, medical institution, IVD knowledge)
Knowledge of quality management system certification and regulatory requirements within CE-marking
Knowledge in relation to external supplier audits/internal audits (relevant for the position as Lead Auditor)

Your personality:
Structured, able to take initiative and to work independently
Good communication skills and customer focus
Interested in cooperation with other cultures and open for travelling approx. 20 - 50 days per year (as Lead Auditor)
Cross cultural collaboration
Fluent in written and spoken English

Presafe Denmark offers:
Challenging and attractive position with professional development through work and training.
High degree of flexibility in the job including the ability to plan and carry out part of your job from your home address.
Colleagues with high technical and regulatory skills.
International network and contact with many different manufacturers of medical devices
Work environment with high focus on well-being and high standards for personal and professional development.

Company & Business Area Description

DNV GL is a global quality assurance and risk management company. Driven by our purpose of safeguarding life, property and the environment, we enable our customers to advance the safety and sustainability of their business.

We provide classification, technical assurance, software and independent expert advisory services to the maritime, oil & gas, power and renewables industries. We also provide certification, supply chain and data management services to customers across a wide range of industries.

Combining technical, digital and operational expertise, risk methodology and in-depth industry knowledge, we empower our customers decisions and actions with trust and confidence. We continuously invest in research and collaborative innovation to provide customers and society with operational and technological foresight.

With origins stretching back to 1864 and operations in more than 100 countries, our experts are dedicated to helping customers make the world safer, smarter and greener.

DNV GL is one of the worlds leading certification bodies. We help businesses assure the performance of their organizations, products, people, facilities and supply chains through certification, verification, assessment, and training services. Partnering with our customers, we build sustainable business performance and create stakeholder trust across all types of industries.

Equal Opportunity Statement

DNV GL 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!

Associated topics: hematopathology, lab, molecular, scientist, services, technician i, technician ii, technician iv, technician lab, technologist

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