Medical Devices-Assessor / Auditor

We have a opportunity for a Medical Device Assessor / Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits / assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR).

Key Accountabilities :

Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors / Assessors.

• Conduct audits (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.
• 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.

To be considered for this role, you’ll require about 10 years of professional experience in relevant field of healthcare products or related activities . : work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs :

In addition to the above you’ll also need to demonstrate the following.

The following attributes are essential :

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.