Medical Device Assessor - Ophthalmic

DNV; Delhi; On-site; INR 2,000,000 - 3,200,000; Full time

Benefits offered by this job

Flexible work arrangements

Generous paid leaves

Medical benefits

Pension and insurance policies

Training and development assistance

Mobile phone reimbursement

Company bonus/Profit share

Job summary

DNV is seeking experienced Medical Device Assessors/Lead Auditors to plan and conduct audits of medical device manufacturing against ISO 13485, IVDR 2017/745 and MDSAP, ensuring accreditation standards are met. You will review documentation and assess conformity while engaging with cross-functional teams and clients to uphold quality promises.

The role emphasizes on-site and desk-based audits, timely reporting, and professional credential maintenance, with growth opportunities within DNV’s Life

Qualifications

• Auditing medical devices against ISO13485 and other standards.
• Desirable MDR assessor qualification from EU Notified Bodies.
• Experience with QA systems and production processes in medical devices.
• Strong technical writing and report-generation capabilities.

Responsibilities

• Audit Quality Management Systems (mainly ISO 13485).
• Check regulatory compliance (EU MDR, FDA 21 CFR 820, MDSAP).
• Review technical documentation, validation, and safety evidence.
• Report nonconformities and recommend corrective actions with follow‑ups.
• Collaborate with cross-functional teams to strengthen client relationships.

Skills

Auditing ISO13485

Regulatory compliance

Technical writing

Stakeholder management

Education

Technical college degree

Postgraduate degree in relevant field

Job description

About Us

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.

About Life Sciences

We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long‑term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance.

About The Role

As part of our continued growth, we are looking to recruit technical and experienced Medical Device Assessors/Lead Auditors. The successful candidate will be responsible for planning and conducting audits/assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/745 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Scope

A Medical Device Auditor evaluates whether medical device companies comply with regulatory requirements and quality standards.

Key Responsibilities

• Auditing Quality Management Systems (mainly ISO 13485).
• Checking compliance with regulations (e.g., EU MDR, FDA 21 CFR 820, MDSAP).
• Assessing technical documentation, validation, and product safety evidence.
• Reporting nonconformities, recommending corrective actions, and ensuring follow‑up.
• Working collaboratively with cross‑functional and customer‑facing teams to strengthen relationships and build confidence.
• Communicating findings clearly and professionally to enhance credibility and reinforce the organization’s quality promise.
• Coordinating effectively with stakeholders to ensure timely delivery of outcomes while maintaining high customer satisfaction.
• Ensuring accurate, error‑free audit report submission and collaborating with GCU for timely review and approval.
• Supporting the sales team with technical insights, quality‑related inputs, and customer‑focused information to strengthen proposals and drive successful deal closures.
• Maintaining required auditor credentials/qualifications and proactively pursuing continuous advancement of relevant certifications.

Key Accountabilities: Assessor / Auditor

• Conduct assessments (desk‑based or on‑site) in accordance with established procedures, maintaining a high standard of service delivery and effective customer communication.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within required timeframes to ensure customer satisfaction and business efficiency.
• Complete projects related to MDR procedures, systems, and documentation as requested by the Operations Manager.
• When required, undertake reviews of files and make certification decisions or recommendations within target timescales and in line with DNV policies and accreditation requirements.
• Carry out audits of the manufacturer’s quality management system and of suppliers or subcontractors when appropriate, drawing up records and reports.
• Conduct surveillance audits, including follow‑up activities, maintaining a high standard of service delivery.
• Project‑manage auditing teams to maximize efficiencies, enhance client satisfaction, and ensure compliance with standards.

Primary Responsibilities (KPIs)

• Compliance & Audit Effectiveness
• Error‑free reports
• Customer Satisfaction
• Sales Growth
• Professional credentials & capability building

Key Behaviors

• Customer‑Centricity
• Collaboration & Stakeholder Management
• Clear, Credible Communication
• Regulatory & Objectivity
• Mutual Respect & Trust

What We Offer

• 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, Group Personal Accident, 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, or grade level.

Equal Opportunity Employer

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.

Position Qualifications: Assessor / Auditor

• Technical college degree or postgraduate degree in a relevant field.
• 10 years of professional experience in the medical device industry, preferably with ophthalmic products, orthopedic implants, or devices of animal origin, and at least 4 years in design, manufacturing, testing, or use of such devices.
• Qualified MDR assessor from a reputed EU Notified Body is desirable.
• Practical experience in the quality management system and specific production processes/technologies for medical devices.
• Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with medical devices.

Preferred Subject Knowledge

• Excellent knowledge of medical device management systems, standards, and compliance/auditing techniques.
• Experience in QA, regulatory, or management systems roles.
• Familiarity with harmonized standards for medical devices.
• Experience with Risk Management EN ISO 14971.
• Background in auditing medical devices.
• Experience auditing against recognized standards.
• Ability to work independently, plan, and prioritise workloads.
• Flair for technical writing essential for exhaustive report writing.

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.