IVDR Assessor

All locations
  • Mumbai, India
  • Pune, India
  • Bangalore, India
  • Vadodara, India
  • Hyderabad, India
  • Chennai, India
  • New Delhi, India
  • Kolkata, India
Business:
Supply Chain & Product Assurance
Position type:
Full Time
Contract type:
Permanent Employee
Job ID:
4710
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Overview

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 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. 

About the role

As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Key Accountabilities: Assessor

  • 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.
  • Conduct Technical File reviews specific for products being authorized.
  • Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
  • 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.

Key Accountabilities: Auditor

  • 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.
  • Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  • 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.
  • If required, undertake reviews of files and make certification recommendations 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.

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 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.

About you

Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.

  • In-Vitro Diagnostic devices:
  • Biology or Microbiology
  • Chemistry or Biochemistry
  • Human Physiology
  • Medical Technology or Biotechnology
  • Medicine, Veterinary Medicine
  • Biomedical science - e.g. haematology, virology, molecular diagnostics
  • Nursing
  • Pharmacy, Pharmacology, Toxicology
  • Physiology

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, and/or experience as an assessor or auditor in a notified body. Specifically:

Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices.

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.

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.

In addition to the above, knowledge of the following would be preferred:

  • An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
  • Work experience in positions with significant QA Regulatory or management systems responsibility.
  • Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices.
  • Experience with Risk Management EN ISO 14971.
  • Medical device experience from auditing/work.
  • Experience auditing against recognized standards.
  • Experience of working under own initiative and in planning and prioritizing workloads.
  • Should have a flair for technical writing, essential for exhaustive report writing.

Benefits

Profit Share

You’ll be part of our global profit share scheme that means we all share in our success as a business. If we profit, so do you. This will be part of our Total Compensation approach each year and depends on our year-end results.

Professional Development

We believe in the 70/20/10 learning model, where 70% of your learning comes from performing your everyday tasks and working on different projects, new areas and initiatives to gain new skills. 20% from working with others and mentoring and the rest from formal education.

Hybrid Work Model

We work in a hybrid model (three days from the office) and have flexible starting hours. This means you can fit your work and life together in a way that works for you.

Global Opportunities

We support you in exploring different career opportunities or shifting between teams, business areas, or geographies, so that you can shape your career according to what you find motivating.

Modern Office in Pune

Our office in Pune has a modern look and feel and you’ll find zones for both focused work and team integration. Sit/stand desks, high-quality adjustable chairs and balance balls are just a few examples of what ergonomic office means at DNV.

Integration Events

Depending on where you are located, you’ll have the opportunity to participate in offsite meetings as well as different initiatives and fun events at the office. We believe that a well-integrated team is a well-functioning team.

Diversity, Equity and Inclusion

At DNV, our commitment to Diversity, Equity, and Inclusion is not only an ethical choice, but also a business decision.

Diversity, fairness, and a sense of belonging are a source of strength for our people, our business, and our customers, and help us to deliver on our purpose, vision, and values.

Learn more

Working here

Since 1864 we’ve been dedicated to safeguarding life, property and the environment. Today we remain at the forefront of new technologies and techniques to help our customers transform for a more sustainable future.

At DNV you can expect to deliver career and industry defining work. You’ll be given the time to build your network, the resources to support your development, and the freedom to satisfy your curiosity and desire to learn.

Learn more

Application Process

FAQs

Welcome to our Frequently Asked Questions page. We’ve put together answers to the questions we’re asked most often to help you find the information you need quickly and easily. Whether you're curious about our recruitment process, benefits or career growth and development, you should find the information below.

How can I find job openings that fit my skills and interests?

Explore our official job search page where you can use filters such as job type, location, and department to find roles that best match your qualifications and career aspirations.

What’s your application process like?

You can apply directly through our careers page by submitting your CV and any other documents we require (i.e. university diplomas/transcripts; visas; previous employment reference letters). Make sure your application is fully completed, and you tailor it to the specific job listing. 

Is your recruitment process designed to be inclusive and accessible?

Yes, it is. We're an equal opportunities employer and welcome applications from all candidates. We’re happy to support your need for any adjustments during the application and hiring process. Share the details of what you need within your application.

What types of interviews might I undergo?

Depending on your role, our interview process may include initial phone screenings, video conferences, and in-person interviews, focusing on both your technical abilities and our shared values. You can ask your recruiter specifically about the interview process for your role. 

How long does the hiring process typically take from application to decision?

The timeline can vary but we make every effort to reply to each candidate as soon as possible and keep everyone up-to-date with where they are in the recruitment process.

How do I know if a recruitment contact is legitimately from your company?

Official communication will come from our verified company email addresses. Carefully check any suspicious looking emails and if you have any doubts, don’t engage.

Are there any fees involved in your recruitment process?

No, we do not charge any fees at any stage of our recruitment process. All applications and interviews are free of charge, we will never ask you to pay any fees or make any payments – please be wary of any requests for payment as these are likely scams.

What should I do if I suspect a job scam?

If you encounter suspicious job postings or recruitment practices, do not provide personal information and contact your recruiter as soon as possible. We take these matters seriously. We will never ask you to pay any fees or make any payments part of our recruitment process.

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Disclaimer

Please beware of recruitment scams that pretend to be from DNV or its employees. We will never ask you to pay any fees or make any payments as part of our recruitment process.