IVDR Assessor

Overview

Assess and audit IVD medical device manufacturers for ISO 13485, IVDR, and MDSAP compliance.

Key Responsibilities

• qms audits
• ivdr projects
• surveillance audits
• audit management
• file review
• certification review

Tasks

-Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. -Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. -Conduct Technical File reviews specific for products being authorized. -Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. -Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. -If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. -Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. -If required, undertake reviews of files 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. -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 communication.

Requirements

• medical devices
• auditing
• iso 14971
• technical writing
• biomedical science
• regulatory qa

What You Bring

-An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. -Experience of working under own initiative and in planning and prioritizing workloads. -Experience auditing against recognized standards. -Medicine, Veterinary Medicine -Should have a flair for technical writing, essential for exhaustive report writing. -Biomedical science - e.g. haematology, virology, molecular diagnostics -Work experience in positions with significant QA Regulatory or management systems responsibility. -Medical device experience from auditing/work. -Chemistry or Biochemistry -Experience with Risk Management EN ISO 14971. -Medical Technology or Biotechnology -Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. -Pharmacy, Pharmacology, Toxicology

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Benefits

-Medical benefits ( Insurance and Annual Health Check-up) -Company bonus/Profit share. -Flexible work arrangements for better work-life balance -Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) -Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) -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)

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