Are you an experienced professional in the medical devices field, seeking to advance your career with a globally recognized organization? DNV is currently hiring a Medical Devices Assessor/Auditor for their Mumbai Metropolitan Region team. This is a full-time, on-site position that offers an opportunity to work with a leading name in assurance and risk management.
About the Company – DNV
DNV is a global leader in assurance and risk management, committed to safeguarding life, property, and the environment. With a mission to inspire trust and transparency, DNV partners with organizations worldwide, offering expertise in standards compliance, safety, and performance improvement.
The company’s Supply Chain and Product Assurance (SCPA) division specializes in helping customers meet increasing demands for trust and transparency in products and supply chains, making DNV a trusted partner for driving sustainable results.
Responsibilities in the Job
As a Medical Devices Assessor/Auditor at DNV, your key responsibilities will include:
- Conducting audits in line with ISO 13485, EU MDR, and MDSAP standards.
- Performing technical file reviews for medical devices, ensuring compliance with accreditation requirements.
- Planning and managing audit projects efficiently to deliver high-quality service to clients.
- Reviewing technical documentation and audit packs.
- Supporting certification decisions while adhering to DNV policies and global standards.
- Project managing teams of assessors/auditors to maximize operational efficiency and client satisfaction.
- Ensuring compliance with harmonized medical device standards for active and non-active devices.
Qualifications for the Role
To qualify for this role, candidates must meet the following criteria:
- A degree in relevant sciences such as Medicine, Pharmacy, Microbiology, Biotechnology, Biomedical Engineering, or related fields.
- At least 10 years of professional experience in the medical devices industry, covering areas such as R&D, manufacturing, quality management, regulatory affairs, or clinical evaluations.
- A minimum of 5 years of experience in quality management is essential.
- Strong knowledge of ISO 13485, MDD 93/42/EEC, MDR 2017/745, MDSAP, and IMDR regulations.
- Proven experience with risk management standards like EN ISO 14971 and sterilization processes.
- Registered as an IRCA lead auditor or equivalent qualification under other recognized bodies.
- Experience in reviewing audit packs and technical documentation.
Skills Required
- Proficiency in auditing techniques and medical device compliance standards.
- Familiarity with both active and non-active devices.
- Solid knowledge of risk management processes and harmonized medical device standards.
- Excellent organizational and communication skills.
- Fluency in English (written and spoken).
- Experience with digital tools and a collaborative mindset to work in a team of assessors/auditors.
