In-vitro Diagnostic Medical Device Assessors

7 months 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

  • Advisor ‐medical Devices and Diagnostics, Digital

    6 months ago

    Delhi, Delhi, India Jhpiego Full time

    Overview: Jhpiego is a nonprofit global health leader and Johns Hopkins University affiliate that is saving lives, improving health and transforming futures. We partner with governments, health experts and local communities to build the skills and systems that guarantee a healthier future for women and families. Jhpiego translates the best science and...

  • Medical devices cws approver

    1 day ago

    Delhi, India SGS Full time

    We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories , working together to enable a better, safer and more interconnected world.Job DescriptionWe are seeking a dedicated ...

  • Medical Devices CWS Approver

    4 days ago

    Delhi, India SGS Full time

    We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity.Our 99,600 employees operate a network of 2,600 offices and laboratories , working together to enable a better, safer and more interconnected world.Job DescriptionWe are seeking a...

  • Medical Device Sales Representative

    4 weeks ago

    Delhi, Delhi, India Viggo Medical Devices Full time

    Viggo Medical Devices, a leading manufacturer of specialized medical devices, seeks a skilled Medical Device Sales Representative to join its team. With a strong presence in the global market, Viggo is dedicated to providing high-quality products and services to patients, hospitals, and life science research institutions.About Viggo Medical...

  • Regulatory Affairs Human Resources Specialist

    3 weeks ago

    Delhi, Delhi, India OMC Medical Limited Full time

    Company OverviewOMC Medical Limited is a leading healthcare company based in the UK, specializing in regulatory services for medical devices. We offer comprehensive solutions to the healthcare industry.Job DescriptionThis is a full-time, remote-based role for a Regulatory Affairs Human Resources Specialist at OMC Medical Limited. The successful candidate...

  • Sales Executive

    7 days ago

    Delhi, India Phoenix Medical Systems Full time

    **Mandatory**: Minimum 1-2 Years of experience in sales, preferably sales of Medical Devices Bachelors in Science/ Biomedical Engineering Languages - English, Hindi & atleast one regional language Should travel across the state to meet doctors and hospitals heads to promote and sell the products Meet or exceeds set Targets. **Desirable**: Experience in...

  • Regional Sales Director for Medical Devices

    3 weeks ago

    Delhi, Delhi, India SLTL Group - Medical Division Full time

    About SLTL Group - Medical DivisionA leading name, SLTL Group situated at Gandhinagar, Gujarat is a pioneer in the manufacturing of laser marking & engraving, laser cutting, laser welding, solar cell scribing / micro-machining system in industrial segment. Our fiber laser marking system with automations like Laser Marking for Bearing, Laser Marking for...

  • Medical Device Sales Representative

    4 weeks ago

    Delhi, Delhi, India Viggo Medical Devices Full time

    Viggo Medical Devices, a pioneering medical device manufacturing company, is seeking an exceptional Sales Executive to spearhead business growth in key territories.We are dedicated to delivering cutting-edge solutions for infusion therapy, anesthesia, critical care, respiratory care, and urology. Our team collaborates closely with hospitals' IPD user groups...

  • Freelancer Assessors Required for Nail Technician

    6 days ago

    Delhi, India Diversified Business Solutions Pvt Ltd Full time

    Require Part Time Invigilator/Assessor in Skill India Govt. for Beauty & Wellness sector. We are an assessment agency responsible for conducting exams and empanelled with Beauty & Wellness Sector Skill Council ,Tourism & Hospitality Sector Skill Council, Sports, Physical Education Fitness & Leisure Skills Council, etc. **Responsibilities and Duties** **#...

  • Endovision | QA Intern

    1 month ago

    new delhi, India Endovision Full time

    Company DescriptionEndovision helps to improve the diagnostic accuracy of upper GI endoscopists and saves their time, enabling them to perform better and faster using deep learning and computational modeling.Role DescriptionThis is a full-time on-site role located in New Delhi for a QA Intern (Medical Device) at Endovision. The QA Intern will be responsible...

  • Assessors Required for Retail Sector

    7 hours ago

    Delhi, India Diversified Business Solutions Pvt Ltd Full time

    Require Part Time Invigilator/Assessor for Skill India Govt.in Security Sector. We are an assessment agency responsible for conducting exams and empanelled with Management & Entrepreneurship and Professional Skills Council (MEPSC) Telecom Sector Skill Council, Electronics Sector Skill Council, etc. **Responsibilities and Duties** **# It requires local as...

  • Global Operations Director for Medical Device Manufacturing

    5 days ago

    Delhi, Delhi, India Careray Digital Medical Technology Co., Ltd. Full time

    Job OverviewAt Careray Digital Medical Technology Co., Ltd., we are seeking an experienced Global Operations Director for Medical Device Manufacturing to lead our factory operations and drive strategic growth. The ideal candidate will possess a deep understanding of medical device regulations, manufacturing operations, and team management.**Job...

  • Medical Device Sales Professional

    3 weeks ago

    Delhi, Delhi, India DNV Full time

    We are seeking a highly skilled and experienced Medical Device Sales Executive to join our team at DNV. As a key member of our sales team, you will be responsible for cultivating new business opportunities and developing long-term partnerships with clients in the medical devices sector.Key Responsibilities:Cultivate new business opportunities and develop...

  • Computer Vision Engineer for Medical Imaging and Diagnostics

    4 weeks ago

    Delhi, Delhi, India VIDAI Full time

    At VIDAI, we're seeking a talented Computer Vision Engineer to join our team in developing cutting-edge medical imaging technologies. This role offers the opportunity to make a meaningful impact in the field of IVF-related research and diagnostics.About the Role:We're looking for an expert in computer vision with a strong background in deep learning and AI....

  • Sales Executive

    2 weeks ago

    New Delhi, India Medinfra Full time

    Sales SpecialistJob Brief -We are looking for a passionate and target-oriented Diagnostic & Medical Device Sales Specialist to help us grow our sales of Medical Equipment and Healthcare Devices.Sales Executive responsibilities include discovering and pursuing new sales prospects, negotiating deals, and maintaining customer satisfaction.If you have...

  • Medical Device Registration Sales Executive

    4 months ago

    Rohini, Delhi, Delhi, India ELT Corporate Private Limited Full time

    **Job Title: Medical Device Registration Sales Executive** **Location: Rohini Sector 3 Delhi 110085** **Department: Regulatory Affairs / Sales** **Reports to: Sales Manager** If you are a motivated individual with a passion for sales and a drive to succeed opportunity. Join us **Key Responsibilities**: - Lead the process of medical device registration,...

  • Medical Device Sales Representative

    7 months ago

    New Delhi, India Savdo Technologies pvt ltd Full time

    **Job description** **Medical Representative (MR) (Devices, Equipment & Consumables)** **Responsibilities**: - Develop and maintain relationships with healthcare providers in the Delhi NCR region. - Promote our _**medical devices, equipment, and consumables **_to healthcare providers and hospitals in the area. - Collaborate with internal teams to ensure...

  • Medical Device Service Expert

    3 weeks ago

    Delhi, Delhi, India Blackfrog Technologies Full time

    At Blackfrog Technologies, a pioneering technology startup based in Manipal, we're revolutionizing the medical device industry. Our cutting-edge solutions have earned us ISO 13485 and ISO 9001 certifications.About UsWe've developed patented systems to improve immunization supply chains and deliver life-saving vaccines to remote areas of India and beyond. As...

  • Sales Director

    2 weeks ago

    Delhi, Delhi, India Chirron Meditek LLP Full time

    Company OverviewChirron Meditek LLP is a leading company in the medical devices industry, with a strong presence in major cities across India, including Delhi, Mumbai, Chennai, and Bengaluru. We work closely with our sales associates and sub-channel partners to market and promote high-value medical equipment from the USA, Switzerland, and Germany.

  • International Medical Device Sales Representative

    1 week ago

    New Delhi, India Euronoxx Reserves ltd Full time

    **International Medical Device Sales Representative** **Benefits** Location: Hybrid (Home-Based and Delhi, India Office), but will be assigned to an international region Pay: Negotiable per year Vacation: Paid time off Schedule: Mondays to Fridays Experience: B2B 4 years (required) **Job Brief** EuroNoxx Medical Group Ltd. A subsidiary of EuroNoxx...