Medical Devices-Assessor/ Auditor

Overview

Conduct audits and assessments of medical devices per ISO 13485, EU MDR & MDSAP.

Key Responsibilities

• device testing
• technical audits
• file review
• compliance review
• project management
• team leadership

Tasks

-If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. -conducting performance testing, evaluation studies or clinical trials of devices. -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. -Review of technical documentation -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. -Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. -Conduct Technical File reviews specific for products being authorized. -work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. -Work actively with a Team of Assessors/ Auditors. -Complete specific projects in relation to medical device procedures, processes, systems and documentation. -Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

Requirements

• iso 13485
• mdr assessor
• irca auditor
• 5+ years
• risk management
• digital tools

What You Bring

-Solid knowledge of non-active devices -Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application -An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques -Experience auditing against recognized standards -Experience with scientific literature searches or peer review in the medical context. -Solid knowledge of sterilization processes -Qualified MDR Assessor from a reputed EU Notified Body, desirable. -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 working with Various Digital Tools. -University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer & Software Technology, Engineering, Nursing, Quality Management. -Registered IRCA lead auditor, or equivalent registration under other recognized body -Excellent organizational and professional communication skills. -5 + years relevant professional experience in quality management is essential. -Fluent in written and spoken English. -Experience of reviewing audit packs -Knowledge of MDR 2017/745, MDSAP, IMDR -Experience with Risk Management EN ISO 14971 -Experience of working under own initiative and in planning and prioritizing workloads

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Benefits

-Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) -Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) -Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) -Medical benefits ( Insurance and Annual Health Check-up) -Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) -Company bonus/Profit share. -Flexible work arrangements for better work-life balance

About Dnv

-With over a century of expertise, the company delivers solutions across sectors like Energy, Marine, and Renewables. -Notably involved in high-profile projects like wind farms, maritime safety, and digital transformation in industries. -The company is renowned for setting the highest standards in risk management and developing technology solutions for sustainability. -Its innovations span the digitalization of energy grids to advancing marine safety standards, driving industries forward. -Headquartered in Norway, the company has evolved from a maritime classification society into a multi-sector advisory giant.

Sector Specialisms

Security Clearance

-background checks will be performed on all final candidates as part of the offer process.