Ivdr Clinical Assessor

Year    MH, IN, India

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: 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. 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.

Benefits


Please note, benefits may depend on your contract type, please confirm with your recruiter.


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.


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.

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Job Detail

  • Job Id
    JD5121998
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    MH, IN, India
  • Education
    Not mentioned
  • Experience
    Year