IVDR Auditor & Assessor

DNV Germany Holding GmbH; United Kingdom; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading assurance company in the United Kingdom is seeking an IVDR Auditor & Assessor to execute audits and assessments. Candidates should have a bachelor's degree in a relevant field and at least 4 years of experience in the IVD medical device industry. Strong customer focus, excellent communication, and the ability to manage a high workload are essential. The role offers flexible work arrangements and various benefits including medical insurance and training assistance.

Benefits

Flexible work arrangements

Generous Paid Leaves

Medical benefits

Training and Development Assistance

Profit Share/Bonus

Qualifications

• Bachelor’s degree or higher in relevant fields such as Biology or Engineering.
• At least 4 years of experience in IVD medical device fields.
• Prior experience in auditing within a Notified Body preferred.

Responsibilities

• Achieving personal KPI targets aligned with organizational goals.
• Perform ISO 13485 and IVDR audits efficiently.
• Plan and deliver various client projects and assessments.

Skills

Customer focus

Excellent communication

Collaboration skills

Fluent English

Education

Bachelor’s degree in a relevant field

Job description

About SCPA

We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

IVDR Auditor & Assessor

Responsibilities :

• Take ownership of achieving personal KPI targets in alignment with team and organizational goals.
• Perform ISO 13485 and IVDR audits and assessments efficiently and competently, in accordance with CE regulations, international standards, applicable regulatory systems, and the company’s certification programs.
• Ensure all work is carried out with the highest level of independence, integrity, and professionalism.
• Support continuous improvement by identifying and implementing enhancements to audit processes, information handling, and cross-functional collaboration within the organization.
• Plan, organize, and deliver various client projects, including assessments, gap analyses, trainings, and customer workshops.
• Maintain active auditor/assessor registration and qualifications to perform designated duties.
• Undertake additional tasks as assigned by the Line Manager.

Benefits

• Flexible work arrangements for better work-life balance
• Generous Paid Leaves (Sick leaves policy/ Annual leaves policy)
• Medical benefits - Annual Health Check-up
• Pension and Insurance Policies – (Pension Insurance, Medical Insurance, Unemployment Insurance, Work related injury insurance, Supplementary Pension)
• Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
• Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Housing Fund, Lunch Policy)
• Profit Share/ Chinese New Year Bonus

*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.

Qualifications

• Bachelor’s degree or higher in a relevant field such as Biology, Microbiology, Chemistry, Biochemistry, Medical Technology, Clinical Medicine, Biomedical Science, Software Technology, Electrical/Electronic/Mechanical Engineering, or Bioengineering.
• At least 4 years of experience in the design, manufacturing, testing, or clinical use of In-Vitro Diagnostic (IVD) medical devices, gained in industry, academia, or hospital environments.
• Prior experience in auditing and assessment within a Notified Body, particularly in the IVD field, is preferred.
• Quality Management System (QMS) auditing experience is desirable; preference given to CCAA-registered QMS auditors.
• Strong customer focus with excellent communication and collaboration skills.
• Fluent in both written and spoken English.
• Capable of managing a high workload and open to frequent travel.

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.