DNV India In-Vitro Diagnostic Assessors Role For Biochem, Biology & Microbiology Candidates

As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 746/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

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.

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

In addition to a relevant educational degree, candidates must have a minimum 4 years of 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 design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (five full technical documentation assessments).

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 blood grouping, immunology (inc. tissue typing), genetic testing and biochemistry.

A PhD in a relevant area for in-vitro diagnostic medical devices can substitute for 3 years of work experience provided it includes 2 years of 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 the 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
• Work in the application of device technology and its use in health care services and with patients
• Testing devices for compliance in accordance with 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;

• 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

DNV is an independent expert in risk management and assurance, with almost 12,000 employees operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.

We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to supporting our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.

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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For those of you who are curious about this role in DNV India, check out some sample interview questions below along with their answers to give you a headstart on your preparations.

1. What experience do you have working with In-Vitro Diagnostic Medical Devices, and what skills do you possess that would enable you to be a successful assessor?
   Answer: The candidate can describe their past work experience in the medical device industry, academia, or hospital environment. They can also talk about their expertise in specific areas such as risk management, clinical trials, or regulatory affairs. They can highlight their educational qualifications, including a technical college degree in a relevant medical area and any certifications or training courses they have completed.
2. What is your understanding of ISO 13485, IVDR 746/2017 and MDSAP standards?
   Answer: The candidate can explain that ISO 13485 is an international standard that outlines the requirements for a quality management system specific to medical devices. IVDR 746/2017 is a regulation specific to in-vitro diagnostic medical devices. MDSAP stands for Medical Device Single Audit Program and is a program that allows medical device manufacturers to undergo a single audit to comply with the regulatory requirements of multiple countries.
3. How do you ensure that you maintain a high standard of service delivery when conducting assessments or audits?
   Answer: The candidate can explain that they follow established procedures, pay attention to detail, and have strong communication and interpersonal skills. They can describe how they work with clients to build strong relationships, set expectations, and provide regular feedback. They can also mention that they stay up-to-date with the latest regulations and standards to ensure that they are providing accurate and relevant assessments.
4. Can you describe a challenging project you worked on as an In-Vitro Diagnostic Medical Device Assessor or Lead Auditor?
   Answer: The candidate can describe a project where they had to navigate complex regulations, work with difficult clients, or deal with unexpected challenges. They can explain how they overcame these obstacles, including any creative solutions they came up with or any resources they utilized. They can also highlight any positive outcomes or lessons learned from the project.
5. How do you stay organized and manage your workload as an In-Vitro Diagnostic Medical Device Assessor or Lead Auditor?
   Answer: The candidate can explain that they have strong project management skills, including the ability to prioritize tasks, delegate responsibilities, and meet deadlines. They can describe any tools or techniques they use to stay organized, such as checklists, calendars, or software programs. They can also mention that they are flexible and adaptable, able to handle multiple projects simultaneously while maintaining a high level of quality.

Editor’s Note: DNV India In-Vitro Diagnostic Assessors Role For Biochem, Biology & Microbiology Candidates. DNV India In-Vitro Diagnostic Assessors Role. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.