In-vitro Diagnostic Medical Device Assessors

3 weeks ago

Delhi, India DNV Full time

Local Unit & Position Description:
Key Accountabilities
- 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 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 as requested by the Medical Devices Operations Manager.
- 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.

Position Qualifications:
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
- Medicine, Veterinary Medicine
- Biomedical science( haematology, virology, molecular diagnostics)
- Nursing
- Pharmacy, Pharmacology, Toxicology

As part of this work experience, risk management experience should be covered:

- Practical experience in conducting or assessing performance evaluation data (including clinical performance data) with in-vitro diagnostic medical devices in one or more of the following areas virology, immunology, Mycology, oncology and infectious disease.Knowledge regarding histocompatibility and immunogenetics, Tissue typing assays (Flow
Cytometry), genetic testing and biochemistry assays.

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.

To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:

- Work in medical devices industry or closely related industries in a research and development, manufacturing, quality management or regulatory affairs capacity
- Work in health services, universities, foundations or other institutions carrying out inspections, audits, performance evaluations, experimental and/or clinical research, including notified bodies
- Testing devices for compliance in accordance to the relevant national or international standards
- Conducting performance testing, evaluation studies or clinical trials of devices

**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

Company & Business Area Description:
DNV is an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems.

Whether certifying products, verifying 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.

Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world’s most successful and forward-thinking companies.

Equal Opportunity Statement:
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

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