Medical Devices-Assessor/ Auditor

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

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.

We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR).

Key Accountabilities:

Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors.

• 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.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Complete specific projects in relation to medical device procedures, processes, systems and documentation.
• If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

To be considered for this role, you ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs:

• work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies.
• work in the application of device technology and its use in health care services and with patients.
• testing devices for compliance with the relevant national or international standards.
• conducting performance testing, evaluation studies or clinical trials of devices.
• 5 + years relevant professional experience in quality management is essential.

In addition to the above you ll also need to demonstrate the following.

• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
• Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application
• Knowledge of MDR 2017/745, MDSAP, IMDR
• Work experience in positions with significant QA, Regulatory or management systems responsibility
• Experience with Harmonized medical device standards and for active & non active devices.
• Experience with Risk Management EN ISO 14971
• Experience auditing against recognized standards
• Experience of working under own initiative and in planning and prioritizing workloads
• Solid knowledge of non-active devices
• Solid knowledge of sterilization processes

The following attributes are essential:

• Work actively with a Team of Assessors/ Auditors.
• Experience of reviewing audit packs
• Review of technical documentation
• Registered IRCA lead auditor, or equivalent registration under other recognized body

• Flexible work arrangements for better work-life balance
• Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave)
• Medical benefits ( Insurance and Annual Health Check-up)
• Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance)
• Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
• Additional Benefits (Long Service Awards, Mobile Phone Reimbursement)
• Company bonus/Profit share.

*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.

• 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.
• Qualified MDR Assessor from a reputed EU Notified Body, desirable.
• Experience with scientific literature searches or peer review in the medical context.
• Fluent in written and spoken English.
• Experience working with Various Digital Tools.
• Excellent organizational and professional communication skills.