Medical Device Assessor/Auditor

EY is hiring for Medical Device Assessor/Auditor for one of its clients.

Location: Any metropolitan cities

Work Mode Work from Home ( need to be flexible with hybrid)

General Shift

Travel – 100 % (75% Domestic)

Notice – Immediate to 60 days

Mandatory Skill set: Auditor, Assessor, MDR Assessor certification body in medical devices, regulatory approvals for medical devices.

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 clients 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, youll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs:

• work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical 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 with the relevant national or international standards.
• conducting performance testing, evaluation studies or clinical trials of devices.
• 5 + years relevant professional experience in quality management is essential.

In addition to the above youll also need to demonstrate the following.

• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
• Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application
• Knowledge of MDR 2017/745, MDSAP, IMDR
• Work experience in positions with significant QA, Regulatory or management systems responsibility
• Experience with Harmonized medical device standards and for active & non active devices.
• Experience with Risk Management EN ISO 14971
• Experience auditing against recognized standards
• Experience of working under own initiative and in planning and prioritizing workloads
• Solid knowledge of non-active devices
• Solid knowledge of sterilization processes

The following attributes are essential:

• Work actively with a Team of Assessors/ Auditors.
• Experience of reviewing audit packs
• Review of technical documentation
• Registered IRCA lead auditor, or equivalent registration under other recognized body

Interested candidates are requested to share their updated resume to mahesh.a2@in.ey.com