ISO13485 & MDR Auditor/Assessor

DNV Germany Holding GmbH; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading certification body in the United Kingdom is seeking a qualified Lead Auditor to conduct audits and assessments for compliance with ISO13485 and related regulations. The role requires a relevant degree and a minimum of 4 years' experience in the medical devices field. You will also be responsible for planing client projects and contributing to continuous improvement in auditing processes. The position offers flexible work arrangements and generous paid leaves.

Benefits

Flexible work arrangements

Generous paid leaves

Medical benefits

Pension and insurance policies

Training and development assistance

Long service awards

Qualifications

• 4+ years of experience in design, manufacturing, or clinical use of medical devices.
• Experience in non-active ophthalmologic devices and emergency care devices.
• Ability to contribute to audit processes and project delivery.

Responsibilities

• Conduct audits and assessments according to ISO13485 and MDR.
• Plan and deliver client projects including assessments and training.
• Maintain qualification as a Lead Auditor/Assessor.

Skills

Customer focus

Communication skills

Interpersonal skills

Team collaboration

Self-motivation

Continuous learning

Fluency in English

Education

Relevant Bachelor or higher degree related to medical science

Job description

• 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.

• 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.

• 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.