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Regulatory Affairs Consultant - Medical Devices

Regulatory Affairs Consultant - Medical Devices

Posted 4 September by Bosch Global Associates Ltd
Ended

Regulatory Affairs Consultant - Medical Devices

Location: UK

Travel: Yes, to France.

Salary: 70,000GBP

Type: Permanent

Other: Permanent Position home-based in the UK with regular travels to France (at least once a month).

Summary:

Part of the Strategic Consulting team.

Responsibilities:

Advise clients on CE marking strategy;

Coordinate and review technical documentation and CE marking Dossier and in particular, clinical evaluation reports and literature reviews;

Prepare and attend meetings with Notified Bodies;

Manage project, client expectations and satisfaction;

Manage external subcontractors assigned to the project, such as medical writers and technical experts;

Advise clients on technical questions such as biocompatibility, risk management, toxicology, usability, sterilization or as required;

Education:

Degree Qualified

At least 5-10 years expertise

Previous Medical device experience in industry, notified body, competent authority or consultancy required

Knowledge of medical device regulations and clinical research regulations

Fluent in English with excellent communication skills;

Organized

Dynamic

REGULATORY CONSULTANT - REGULATORY AFFAIRS / REVIEWER / DEVICES / ACTIVE IMPLANTABLES / AIMD / SOFT TISSUE / ELECTRICAL / ELECTRICAL / MEDICAL DEVICES / REGULATIONS / EVALUATION / CLINICAL / ELECTRONICS / PHYSICS / ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO SURGICAL / ELECTRO MECHANICAL / QA / QMS / QUALITY MANAGEMENT / QUALITY ASSURANCE / ISO13485 / FDA / 21 CFR / 2001/82/EC / MEDICINAL / DRUG DELIVERY / DRUG COMBINATION / INHALATION / BIOCOMPATIBILITY / RISK ASSESSMENT / TECHNICAL REVIEWER / SCHEME MANAGER / TECHNICAL MANAGER / VALIDATION / VERIFICATION / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / 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 / INFUSION / BOSTON SCIENTIFIC / STRYKER / BIOMED / BIOMET / COVIDIEN / MEDTRONIC / SMITH AND NEPHEW / DEPUY / ORTHOSOL / SYNTHES / OLYMPUS / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCULAR / VASCULAR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / RADITATION/ BENELUX, BELGIUM, SWITZERLAND, FRANCE, GERMAN / ENGLAND / US / USA / EUROPE / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / BARD / MEDTRONIC / KARL STORZ / TUV / SGS / KEMA / DEKRA / INTERTEK / UL / UNIVERSAL LABORATORIES / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / SUPERSONIC / RELOCATE / SWEDEN / AUSTRIA / BELGIUM / FRANCE / PARISOLYMPUS / BESPAK / DIAGNOSTICS / COOPERVISION / SAUFLON / BAXTER / BBRAUN / NIKKISO / TERUMO / OLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / DRUG DELIVERY / CAREFUSION / SIEMENS / PHILIPS / SGS / LRQA / LGE / BUREAU VERITAS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / BIOMET / LOMBARD / MEDICAL / BIOMEDICAL / VARIAN / SUPERSONIC / MEDTRONIC / TISSUE REGENIX / SCIENTIFIC / SCIENCE / CLINICAL / PROJECT MANAGEMENT / PROJECT MANAGER / CRO / CONTRACEPTIVES/SSL/MOLYNCKE/SCHOLL/CONDOMS/P&G/PASANTE/SURGICAL GLOVES / SCIENTIFIC / FORMULATION CE MARKING / CERTIFICATION / USA / UK / UNITED KINGDOM / LONDON / MILTON KEYNES / BEDFORDSHIRE / MIDLANDS / OXFORD / OXFORDSHIRE / CAMBRIDGESHIRE / SOUTH WEST / SWINDON / WILTSHIRE / GLOUCESTER / GLOUCESTERSHIRE / BRISTOL / SOMERSET / SOUTH WALES / CARDIFF / LONDON / KENT / SUSSEX / 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 / SHEFFIELDBIOLOGICAL / CHEMISTRY / OPHTHALMIC / CONTACT LENSE / BIOCHEMISTRY / UK / UNITED KINGDOM / LONDON / SOUTH / SOUTH EAST / NORTH WEST / ENGLAND / RELOCATE / MIDLANDS / OXFORD / HOME COUNTIES / MILTON KEYNES / SOUTH WEST /CONTRACEPTIVES/SSL/MOLYNCKE/SCHOLL/CONDOMS/P&G/SURGICAL GLOVES/LATEX/SILICON/SSL/RECKITS/TISSUE ENGINEERING/TISSUE REGENIX/ADVANCE MEDICAL SOLUTIONS/SOFT TISSUE/MEDTRADE/CONVATEC/TISSUE SCIENCE

Required skills

  • Clinical
  • Medical Devices
  • Regulatory Affairs
  • CLINICAL EVALUATION

Reference: 32915550

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