DNV

Independent assurance and risk management firm.

ISO 13485 & MDR Auditor/Assessor

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours

Full-timeNo salary listedIn-person

About the Job

Requirements

A relevant bachelor's degree or higher related to medical science and the medical device area, such as biology or microbiology; biomechanical engineering; chemistry or biochemistry; medicine and clinical practice; computer and software technology; or electrical, electronic, mechanical, or bioengineering.
At least 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments.
Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities.
Fluency in written and spoken English.
Comply with applicable statutory requirements and background checks conducted in accordance with country-specific laws and practices.

Responsibilities

Conduct audits and assessments in accordance with ISO 13485, MDSAP, and MDR, based on applicable directives, regulations, harmonized standards, and other regulatory requirements, following DNV's accredited certification program and procedures.
Ensure all auditing activities are independent and ethical, upholding DNV's values of integrity and impartiality.
Contribute to continuous improvement by identifying and driving enhancements in audit processes, information management, and service delivery across teams.
Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned.
Perform additional duties as assigned by the line manager to support team and business objectives.

Desired Qualifications

Experience with product groups MDN1206 (non-active ophthalmologic devices), MDN1201 (non-active devices for anesthesia, emergency, and intensive care), or MDN1202 (non-active devices for administration, channelling, and removal of substances, including dialysis).
High customer focus and service orientation.
Strong communication and interpersonal skills.
Ability to work collaboratively in teams and across functions.
Self-motivation and commitment to continuous learning and development.

Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards and other applicable regulatory requirement following DNV’s accredited certification program and procedure.
Ensure independent and ethical of all auditing activities, upholding DNV’s values of integrity and impartiality.
Contribute to continuous improvement efforts by identifying and driving enhancements in audit processes, information management, and service delivery across teams.
Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned.
Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities.
Perform additional duties as assigned by the line manager to support team and business objectives.

Relevant Bachelor or higher degree related to medical science and medical device area. Core disciplines: biology or microbiology; biomechanical engineering; chemistry or biochemistry, medicine and clinic practice; computer and software technology; electrical, electronic, mechanical or bioengineering. etc.
Minimum 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments. Prefer product group: MDN1206 non-active ophthalmologic device, MDN1201 non-active deice for anesthesia, emergency and intensive care, MDN1202 non-active device for administration, channelling and removal od substances, including dialysis.
High customer focus and service orientation
Strong communication and interpersonal skills
Proven ability to work collaboratively in teams and across functions
Self-motivated with strong commitment to continuous learning and development
Fluency in both written and spoken English is required

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.

Flexible work arrangements for better work-life balance
Generous Paid Leaves (Annual Paid Leave, Sick Leave)
Medical benefits (Standard medical check-up)
Pension and Insurance Policies
Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Professional Membership Fees)

*Benefits may vary based on position, tenure/contract/grade level*

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.

About the Company

DNV

Independent assurance and risk management firm.

DNV is a global assurance and risk management firm that certifies the safety and compliance of a company’s systems, products, and supply chains across industries like maritime, energy, healthcare, and food. Its work involves independent verification and certification, using standardized, science-based criteria to assess ships, pipelines, safety management, and other processes, ensuring they meet agreed standards. What sets DNV apart is its long history and wide reach: born from 19th-century maritime risk assessment, it has grown into a multinational organization with about 15,000 employees in over 100 countries, and it combines deep domain expertise with a focus on safety and sustainability, including digitalization and the energy transition. The company’s goal is to be the trusted voice on safety and sustainability, helping clients manage risk, improve reliability, and demonstrate compliance through trusted certifications and assessments.

Company size: 10,001+
Company stage: Grant
Total funding: $2.1M
Headquarters: Bærum, Norway
Founded: 1864

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