Integrated Clinician/clinical Assessor - Mumbai, Maharashtra, India - DNV
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 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:
We are looking for an Integrated Clinician/Clinical Assessor in Medical Devices to join our Medical Technologies team.
Main responsibilities:
- Assessment of clinical aspects of technical documentation of all medical devices classes according to the requirements laid down in the European Medical Device Regulation (MDR) and other related regulations/standards
- Preparing a list of findings in case of nonconformities with the requirements of the MDR
- Handling of clinical evaluation consultation procedures for certain class III and class IIb devices
- Evaluation of the Summary of safety and clinical performance reports for implantable and class III devices
- Provide support during clinical audits of medical device manufacturers as a clinical expert (may need a certain level of travel)
- Serving as an internal point of contact for clinical matters as part of the interfaces with other departments, offering support and close exchange with colleagues
- Deliver all services within necessary timelines while maintaining highquality
What we offer:
Flexible work arrangements for better work-life balance
- Generous Paid Leaves (Annual Paid Leave, Special Paid Leave)
- Pension and Insurance Policies (Corporate insurance policies, Accident insurance, Unemployment insurance, Medical insurance, National Pension, Travel insurance )
- Additional Benefits (Long Service Awards, Retirement Allowances, Housing Allowances, Festive Allowances, Transportation Allowances, Meal Allowances, Tuition Assistance for Employees Kids)
About you:
Required:
- Medical doctor with a specialization in radiology or with a specialization in dermatology with 35 years of clinical experience including patient care
- For nonphysician, qualified clinical staff with national certification in diagnostic imaging with 510 years of clinical experience is required (e.g. clinical image evaluator with national qualification)
- Excellent communication skills in English (both written and spoken)
Preferred:
- Excellent organizational and professional communication skills
- Forwardthinking mindset and an understanding of the Notified Body environment
- A thorough, accurate, and riskbased working style & understanding of the big picture while being able to dive into the detail
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