
Integrated Clinician/clinical Assessor
2 weeks ago
**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 non-conformities 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 high-quality
**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)
*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**:
Required:
- Medical doctor with a specialization in radiology or with a specialization in dermatology with 3-5 years of clinical experience including patient care
- For non-physician, qualified clinical staff with national certification in diagnostic imaging with 5-10 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
- Forward-thinking mindset and an understanding of the Notified Body environment
- A thorough, accurate, and risk-based working style & understanding of the big picture while being able to dive into the detail
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