IVDR Clinical Assessor

All locations
  • Mumbai, India
  • Pune, India
  • Bangalore, India
  • Chennai, India
  • Hyderabad, India
  • Vadodara, India
  • New Delhi, India
  • Kolkata, India
Business:
Supply Chain & Product Assurance
Position type:
Full Time
Contract type:
Permanent Employee
Job ID:
4711
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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

DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices.

Main tasks in this role are:

Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746.

Evaluation of the summary of safety and performance reports for high-risk IVD medical devices.

Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746.

Education and Competencies required:

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

What we offer
  • A competitive compensation and benefit package
  • DNV training and qualification program
  • A professional community in a prestigious technological company
  • Possibilities to work with interesting and challenging projects
  • Access to an extensive competence network
  • 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.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

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 Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices.

A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation.

Personal Qualities:

  • Analytical approach.
  • Strong communication skills.
  • Customer focus.
  • Excellent reporting skills.
  • Ability to work independently and efficiently.
  • Ability to form recommendations on certification in complex cases.

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.