IVDR Assessor/Auditor
Dnv
Assess and audit IVD medical devices per ISO 13485, IVDR, MDSAP
22 days ago ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Full Time
Loughborough, England, United Kingdom
Hybrid
Company Size
12,000 Employees
Service Specialisms
Maritime
Energy Systems
Business Assurance
Digital Solutions
Accelerator
Cyber Security
Supply Chain & Product Assurance
Sector Specialisms
Industrial
Energy
Infrastructure
Buildings
Residential
Commercial
Water Resources
Heavy Civil
Role
What you would be doing
surveillance audits
site assessments
ivdr projects
audit management
file review
qms audits
- Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
- Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication.
- Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
- Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
- Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
- Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
- If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
- If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements.
- Conduct Technical File reviews specific for products being authorized.
- Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate, and to draw up records and reports on the corresponding audits.
What you bring
phd
iso 14971
risk management
technical writing
qa regulatory
audit experience
- Pharmacy, Pharmacology, Toxicology
- Biomedical science - e.g. haematology, virology, molecular diagnostics
- Medicine, Veterinary Medicine
- In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, as well as experience as an assessor or auditor in a notified body. Specifically:
- Experience with Risk Management EN ISO 14971;
- An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques;
- A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.
- Experience of working under own initiative and in planning and prioritizing workloads;
- Medical Technology or Biotechnology
- Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices;
- Experience auditing against recognized standards;
- Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology.
- Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices.
- Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.
- Chemistry or Biochemistry
- Medical device experience from auditing/work;
- Work experience in positions with significant QA Regulatory or management systems responsibility;
- Should have a flair for technical writing, essential for exhaustive report writing.
- Genetic testing
- A supportive and friendly team of experts and innovators
- A competitive salary and benefits package
- A stimulating and diverse work environment with opportunities for professional growth and development – learn from highly skilled colleagues and customers
- Social benefits as per DNV location (local conditions apply)
Information not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearance- background checks will be conducted on all final candidates as part of the offer process.
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Company
Overview
1864
Year Founded
Established in 1864, the company has a long-standing history and has evolved into a multi-sector advisory giant.
- With over a century of expertise, the company delivers solutions across sectors like Energy, Marine, and Renewables.
- Notably involved in high-profile projects like wind farms, maritime safety, and digital transformation in industries.
- The company is renowned for setting the highest standards in risk management and developing technology solutions for sustainability.
- Its innovations span the digitalization of energy grids to advancing marine safety standards, driving industries forward.
- Headquartered in Norway, the company has evolved from a maritime classification society into a multi-sector advisory giant.
- We care for each other, our customers, our planet, and we take care of ourselves.
- We dare to explore, to experiment, to be different, and to be courageous, curious and creative.
- We share our experience and knowledge. We collaborate with each other and our customers, and we continue to grow and develop as a result.
50% Carbon Reduction
Emissions Target
Targets a 50% reduction in carbon footprint per employee and per revenue by 2025 compared to 2019 levels.
48% Emissions Drop
Employee Emissions
Achieved a 48% reduction in emissions per employee in 2024 compared to 2019.
52% Electric Cars
Sustainable Fleet
52% of globally used cars are fully electric or hybrid vehicles.
85% Renewable Energy
Energy Source
85% of electricity used in offices and labs comes from certified renewable sources.
- Full offsetting of 41.4 ktonnes CO₂ emissions in 2022.
- Switching to 100% renewable electricity, reducing office space, and cutting emissions from business travel.
- Complies with European Sustainability Reporting Standards and ISO certifications.
- Net-zero operations achieved through emission reduction and full offsetting.
12,500+ employees
Global Workforce
The company employs over 12,500 individuals across 100+ countries, reflecting a highly diverse workforce with 100+ nationalities.
35% female employees
Female Representation
Approximately 35% of permanent employees are female, representing notable progress from 29.7% in 2013.
30% female managers
Managerial Diversity
Female representation at the managerial level stands at 30%, up from 20.7% in 2013, showcasing progress in leadership roles.
- DEI strategy: foster inclusive culture; embrace diverse identities, backgrounds, experiences and perspectives; embed equity in policies, processes and practices.
- DEI commitments include leadership engagement, management system for diversity, embedding DEI into all processes, awareness/training programs, discrimination reporting/investigation procedures, alignment with UN SDGs, and transparent performance reporting.
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