IVD Technical Product Specialist - IVD - Home Based

Posted 1 week ago by Bosch Global Associates Ltd

IVD Technical Specialist - IVD - Home Based UK.

Type: Permanent.

Salary: 40-55k.

Location: Home / Office based UK or Office Based.

Travel: Yes, >20%.

Reason: Growth.

Job 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 development and delivery of training materials to assessors.
  • Support Competent Authority (MHRA) activities on as needed basis e.g. MHRA audits.
  • Participate in the development of requirements and assessment methods.
  • Provide guidance and support to customers as required.
  • Participate in client training and customer forums.
  • UK/Overseas travel is required.

Job Requirements:

  • At least a Degree or equivalent in Life Science discipline e.g. Biochemistry, Applied Biology. PhD would be an advantage.
  • At least 4 years hands-on experience within 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. A particular interested in candidates with Molecular Biology expertise.
  • Hands-on knowledge of 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).

Desirable:

  • Auditing experience, ideally with another registration body. IRCA member.
  • Experience with ISO 13485/9001.
  • Fluent English language skills essential and other EU language skills.

List A / IVD 0101 ABO System / IVD 0102 Rhesus (C, c, D, E, e) / IVD 0103 Anti-Kell IVD 0201 HIV infection (HIV 1 and 2) / IVD 0202 HTLV I and II / IVD 0203 Hepatitis B, C and D / List B / IVD 0301 Anti-Duffy and anti-Kidd / IVD 0302 Irregular anti-erythrocytic antibodies / IVD 0303 Congenital infections: rubella, toxoplasmos / IVD 0304 Hereditary disease: phenylketonuria / IVD 0305 Human infections: cytomegalovirus, chlamydia / IVD 0306 HLA tissue groups: DR, A, B / IVD 0307 Tumor marker: PSA / IVD 0308 Risk of trisomy 21 (incl. software) / IVD 0309 Device for self-diagnosis: device for the measurement of blood sugar / CE MARKING / Molecular biology - assay development + validation + risk managemen / Companion diagnostics - assay development + validation+ risk management / Blood grouping - assay development + validation+ risk management in-depth knowledge of the CTS (Common Technical Specifications) / HIV/ Hepatitis- assay development + validation+ risk management in-depth knowledge of the CTS / Sexually transmitted diseases - assay development + validation+ risk management / Cancer diagnostics (IVD not MDD) - assay development + validation + risk management / Manufacturing knowledge/ internal auditor with the in-depth 7 years technical / QMS / technical) / Principle Biochemist Blood Transfusion Service/ Red Cross and developed or validated assays for HIV/ Hepatitis / Microbiology) Beckam Coulter , Olympus 7300 ( blood group), IBG ( Inverness Blood Group ) Cobas (PCR technique) and am familiar with ISOS 9000/9001 Quality System / BLOOD GROUPING / IVD / ANTI KIDD / DUFFY / DIAMED / GEL / ANTI KIDD / DUFFY / ASSAY DEVELOPMENT / MOLECULAR BIOLOGY / BIOLOGICALS / CANCER / CLINICAL / MEDICAL / DESEASE / SCIENTIST / QA / QUALITY ASSURANCE / 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / CERTIFICATION / NOTIFIED BODY / DEKRA / KEMA / TUV / CERTIFICATION / CE MARKING / IVD / HIV / ASSAY DEVELOPMENT / DIAGNOSTICS / BIOCHEMICAL / BIOMEDICAL / MICROBIOLOGY / PRODUCTION / MOLECULAR BIOLOGY / HIV / BLOOD / DIAGNOSTICS / RISK ASSESSMENT / RISK MANAGEMENT / TECHNICAL / MOLECULAT BIOLOGY / VALIDAITON / HEPATITUS / BLOOD BANKS / BLOOD GROUPING / SEXUALLY TRANSMITTED / DESEASES / CANCER / BIOCHEMIST / BIOCHEMISTRY / TRANSFUSION / IVD / CERTIFICATION / USA / UK / UNITED KINGDOM / LONDON / MILTON KEYNES / BEDFORDSHIRE / MIDLANDS / OXFORD / OXFORDSHIRE / CAMBRIDGESHIRE / SOUTH WEST / SWINDON / WILTSHIRE / GLOUCESTER / GLOUCESTERSHIRE / BRISTOL / SOMERSET / HAMPSHIRE / SURREY / MIDDLESEX / BERKSHIRE / SE LONDON / KENT / SUSSEX / NORTHAMPTON / NORTHAMPTONSHIRE / EAST ANGLIA / SUFFOLK / NORFOLK / ESSEX / CAMBRISGESHIRE / CAMBRIDGE / PETERBOROUGH / BEDFORD / HERTS/ HERTFORDSHIRE / INTERTEK / UL / BUCKS / BUCKINGHAMSHIRE / HEREFORSHRIE / STAFFORD / STAFFORDSHIRE / CHESHIRE / NOTTINGHAM / NOTTINGHMASHIRE / MANCHESTER / M62 / M1 / M25 / M20 / M5 / M6 / LANCASTER / LANCASHIRE / LEEDS / YORK / YORKSHIRE / ENGLAND / WALES / MILTON KEYNES / BEDFORD / BEDFORDSHIRE / NORTHAMPTON / HAMPSHIRE / BASINGSTOKE / SOUTHAMPTON / BRIGHTON / SOUTH EAST / CAMBRIDGE / CAMBRIDGESHIRE / NORFOLK / NORWICH / SUFFOLK / IPSWICH / HAVERHILL / ROMFORD / MIDDLESEX / SLOUGH / WEST SUSSEX / SURREY / MAIDSTONE / DARTFORD / TONBRIDGE / HYTHE / ASHFORD / BIRMINGHAM / LEICESTER / LEICESTERSHIRE / NOTTINGHAM / NEWCASTLE / YORK / GRIMSBY / LINCOLN / LINCOLNSHIRE / WORCESTER / WORCESTERSHIRE / WARWICK / WARWICKSHIRE / HEREFORD / HEREFORDSHIRE / SOMERSET / BATH

Required skills

  • Medical Devices
  • Molecular Biology
  • IVD
  • Product Certification
  • CE marking

Application questions

do you have IVD expertise in R&D, Lab or Manufacturing - please indicate?
do you have regulatory expertise or strong knowledge of regulatory documentation - please indicate?
do you have a good understanding or appreciation for quality standards - please indicate?
do you have 13485 QMS knowledge or CE expertise - please indicate?
do you have auditing or assessment expertise or knowledge - please indicate?

Reference: 29584089

Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Report this job