0800 292 2332
0800 292 2332


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Technical and Regulatory Auditor - UAE

Salary: 80000

Type: Permanent

Conditions: Full Time

Reference: DB2011

Description

Technical and Regulatory Auditor - UAE.

Remuneration: circa 80k Sterling plus 20-40% bonus.

Reports to: CAB Technical Manager.

Additional information about the job:

  • Full-time.
  • Permanent or Fixed Term.
  • Work permit: Yes, sponsored
  • Working hours: Flexible.
  • Job location: Riyadh, Saudi Arabia.
  • Work permit: Yes.
  • Attractive Compensation/Salary: Negotiable salary + bonus, housing, transport, etc. The salary paid might be tax free (depending on country)

Position overview:

  • Build strong relationship with SFDA through quality of work and effective handling of the reviews to further gain market share of the SFDA/CAB Program and win additional business opportunities from SFDA
  • Conducts reviews of MDMA applications based on customer requirements

Regular tasks and responsibilities:

  • Manages and supports processing of SFDA applications through Technical Reviewers in-line with SFDA / NB CAB Program requirements based upon knowledge and expertise with global market access programs for medical devices
  • Participates in SFDA knowledge share forums / monthly MDMA meetings to develop technical requirements for the reviews
  • Builds strong relationships with local and remote Technical Reviewers, Notified Body staff, SFDA/NB CAB Program Manager, Sales, Senior Operations Management, SFDA staff, etc.

Requirements:

The candidate should have the following qualifications/competencies:

  • Industry Experience: Working experience in the medical devices industry (design, manufacturing, QA/RA)
  • Field Experience: Notified Body/Registrar, Competent Authority, Consultant or Medical Devices Industry (e.g. RA Mgr.)
  • Practical Experience in Regulations: The candidate must have compiled or assessed technical dossiers / technical files acc. to EU Regulations. Canadian and US Regulations are preferred but not required.
  • Theoretical Knowledge in Regulations: The candidate must have comprehensive theoretical knowledge in EU Regulations plus US or Canadian Regulations.
  • Auditor Experienc: IRCA certified Lead Auditor for ISO 13485 and EU Legislation(s). Auditors also qualified for CMDCAS and JPAL audits are preferred but it is not required.
  • Education: Bachelor or Master Degree in (medical) engineering, science, medicine or similar
  • Language skills: Fluent English language skills required and other EU / Arabic language desirable
  • Theoretical knowledge in safety and process standards preferred: ISO 14971, IEC 60601, IEC 62304, IEC 62366
  • Computer Programs: Good application knowledge of MS Word and MS Excel. Experience with Oracle is preferred.
  • Cultural Environment: Experience in cultural differences between Middle East and Western countries is preferred

TECHNICAL MANAGER / REGULATORY MANAGER / MEDICAL DEVICES / CLASS 3 / CLASS III / FDA / SUBMISSIONS / RA MANAGER / REGULATORY SPECIALIST / REGUALTORY AFFAIRS / MANAGER / LEADER / CE MARKING / CERTIFICATION / SGS / IRCA / LRQA / UL / TUV / BSI / INTERTEK / DEKRA / LNE / BV / IRCA / BUREAU VERITAS / 9001 / 9000 / 60601 / 60602 / ACTIVE DEVICES / ELECTRICAL / ELECTRONICS / ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO MECHANICAL / ELECTRO MEDICAL / LEAD AUDTITOR / ASSESSOR / TECHNICAL FILES / TECHNICAL REVIEWER / PROJECT ENGINEER / PROJECT MANAGER / QA / QUALITY ASSURANCE / ISO 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / PRODUCTION / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / HEALTHCARE /MEDICAL / ENGINEERING / TECHNOLOGY / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / INFUSION / BOSTON SCIENTIFIC / DRUG DELIVERY / IVD / MDD / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / NEUROVASCULAR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / ITALY / SWEDEN / SPAIN / NETHERLANDS / FRANCE / UK / SWITZERLAND / US / USA / AMERICA / EU / EUROPE / ABBOTT / SANOFI / HEALTHCARE / TUV / SGS / CE MARKING / CERTIFICATION / KITE MARK / BRISTOL MYERS / CONVATEC / CONSULTANT / CONSULTANCY / ROCHE / SAI GLOBAL / SAUFLON / SMITH NEPHEW / DEPUY / SYSTAGENIX / TISSUE REGENIX / TEVA / CE MARKING / 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 / 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 / RELOCATE / EUROPE / UAE / BAHRAIN / DAMMAM AL JUBAIL / ABU DHABI / DUBAI / RUWAIS / AL AIN / RAS AL-KHAIMAH / MUSCAT / SOHAR / OMAN / FUJAIRAH / KHASAB / RIYADH / SAUDI ARABIA / KUWAIT / DOHA / IRAQ / BASRAH / IRAN / BASRAH / SHIRAZ / MEDINA / BURAYDAH / JEDDAH / MECCA / YEMEN / DJIBOUTI / JORDAN

 

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