Kablio AI
AI Turbo Recruiter
Want to hear how I work? Hit play.Find roles with Kablio AI to help build and power the world.Kablio AI helps you secure roles in construction, clean energy, facilities management, engineering, architecture, sustainability, environment and other physical world sectors.
Get hired, get rewarded!
Land a job through Kablio and earn a 5% salary bonus.
Exclusive benefits
5%Bonus
Medical Devices-Assessor/ Auditor
Dnv
Assess and audit medical devices per ISO 13485, EU MDR, MDSAP standards.
6d ago
Expert & Leadership (13+ years)
Full Time
Delhi, Delhi, India
Office Full-Time
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
auditing
technical review
device testing
project management
compliance testing
clinical evaluation
- Complete specific projects in relation to medical device procedures, processes, systems and documentation.
- Work actively with a Team of Assessors/ Auditors.
- Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
- Review of technical documentation
- testing devices for compliance with the relevant national or international standards.
- Conduct Technical File reviews specific for products being authorized.
- work in the application of device technology and its use in health care services and with patients.
- conducting performance testing, evaluation studies or clinical trials of devices.
- Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
- Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
- If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
- work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies.
What you bring
iso 13485
mdr
irca auditor
iso 14971
5 years
english
- Experience of reviewing audit packs
- Solid knowledge of non-active devices
- Fluent in written and spoken English.
- Knowledge of MDR 2017/745, MDSAP, IMDR
- Experience with Harmonized medical device standards and for active & non active devices.
- Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application
- 5 + years relevant professional experience in quality management is essential.
- Experience of working under own initiative and in planning and prioritizing workloads
- Experience auditing against recognized standards
- Registered IRCA lead auditor, or equivalent registration under other recognized body
- Work experience in positions with significant QA, Regulatory or management systems responsibility
- Solid knowledge of sterilization processes
- University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management.
- Experience working with Various Digital Tools.
- Experience with Risk Management EN ISO 14971
- Excellent organizational and professional communication skills.
- Qualified MDR Assessor from a reputed EU Notified Body, desirable.
- Experience with scientific literature searches or peer review in the medical context.
- An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
- Medical benefits ( Insurance and Annual Health Check-up)
- Company bonus/Profit share.
- Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave)
- Additional Benefits (Long Service Awards, Mobile Phone Reimbursement)
- Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
- Flexible work arrangements for better work-life balance
- Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance)
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.
People also searched
Quality Control Jobs in South Delhi IndiaRisk Manager Jobs in South Delhi IndiaQuality Manager Jobs in South Delhi IndiaQuality Assurance Jobs in South Delhi IndiaQuality Inspector Jobs in South Delhi IndiaQuality Engineer Jobs in South Delhi IndiaQuality Control Jobs in West Delhi IndiaRisk Manager Jobs in West Delhi India
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 COâ‚‚ 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.
Kablio AIIf you're someone who helps build and power the world (or dreams to), Kablio AI is your pocket-sized recruiter that gets you hired.
Copyright © 2025 Kablio