Location: Home based Ireland - Anywhere.
Salary: Negotiable depending on expertise typically = 45-55k GBP.Overview:
In Vitro Diagnostics Medical Devices (IVD) are some of the most regulated products in the world. In this role, you will be part of the Medical Regulatory Team. Working with limited supervision, you will independently assist and support processing of manufacturer submissions to the IVD Directive 98/79/EC and, where applicable, ISO13485.Responsibilities:
- Perform contract review/project planning for technical file/design dossier evaluations and quality management system audits.
- Assess technical file/design dossier and quality management systems against European Directives, essential requirements and latest common technical specifications.
- Support regular quality system and technical audits, including unannounced audits.
- Subject to training and qualification milestones, perform key CE certification decision making responsibilities to support safe products to market.
- Perform key development and support of IVD processes for future CE IVD Regulations.
- Participate in the development and delivery of training materials to UL assessors.
- Support Competent Authority (MHRA) activities on as needed basis eg MHRA audits.
- Participate in the development of requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
- Provide guidance and support to customers as required. Participate in client training and customer forums.
- UK/overseas travel is required.
- Educated to at least Degree level or equivalent in a Life Science discipline, eg Biochemistry, Applied Biology. A PhD would be an advantage.
- At least 4 years’ hands-on experience within the In Vitro Diagnostics industry in one or more of the following roles - R&D, Manufacturing or Quality Assurance/Regulatory Affairs.
- Working knowledge and thorough understanding of the principles of following areas: Immunoassay (all currently available variants), NAT, Rapid Assay Formats, Self-test device technologies and general serology devices. UL is particularly interested in candidates with Molecular Biology expertise.
- Hands-on knowledge of the design, evaluation and manufacture of assays mentioned in In Vitro Diagnostics Directive:
- List A (ABO, rhesus, anti-Kell blood grouping, HIV, HTLV Hepatitis B, C, D)
- List B (anti-Duffy, anti-Kidd blood grouping, Irregular anti-erythrocyte blood grouping, Rubella, Toxoplasma, PKU, Cytomegalovirus, Chlamydia, HLA (DR, A, B) Tissue typing, PSA, Trisomy 21, Blood sugar self-test, Self Test Devices (Allergy, Cholesterol, Pregnancy, Ovulation, Osteoporosis etc).
- Auditing experience, ideally with another registration body.
- IRCA member.
- Experience with ISO13485/9001.
- Fluent English language skills essential and other EU language skills desirable.
- Ability to demonstrate Critical Behaviors for Success to include:
- Process orientated to deliver business success;
- Excellent verbal and written communication skills;
- Confident, calm and decisive personality;
- Strong innovative and analytical skills;
- Ability to deal professionally with confrontation
IVD / IN VITRO DIAGNOSTICS / BLOUD GROUPING / BIOSCIENTIFIC / BIOMEDICAL / QA / QUALITY ASSURANCE / 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / SOFTWARE / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / CLASS 1 / CLASS 2 / CLASS 3 / CLASS 3A / CLASS 3B / CLASS I / CLASS II / CLASS III / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / ELECTRO MEDICAL / ELECTRO-MECHANICAL / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / EUROPE / UK / UNITED KINGDOM / IVD / MEDICAL DIAGNOSTICS / IN VITRO DIAGNOSTICS / ENGLAND / EUROPE / RELOCATE / US / USA / AMERICA / CALIFORNIA / GERMANY / FRANCE / VALIDATION / ASSAY DEVELOPMENT / BIOCHEMICAL / BIOMEDICAL / MICROBIOLOGY / PRODUCTION / MOLECULAR BIOLOGY / HIV / BLOOD / DIAGNOSTICS / RISK ASSESSMENT / RISK MANAGEMENT / TECHNICAL / UK / LONDON / OXFORDSHIRE / BUCKS / BUCKINGHAMSHIRE / CAMBRIDGE / CAMBRIDGESHIRE / NORTHAMPTON / BIRMINGHAM / WARWICK / WARWICKSHIRE / HERTS / HERTFORDSHIRE / FRANKFURT / BERLIN / PARIS / IRELAND / DUBLIN / SLIGO / CORK / LIMERICK / MANCHESTER / SCOTLAND / LIVERPPOL / CHESHIRE / KILLARNEY / WATERFORD / CAVAN / CASTLEBAR
- Medical Devices
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