DRUG DELIVERY PRODUCT EXPERT - MEDICAL DEVICES - NETHERLANDS

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DRUG DELIVERY PRODUCT EXPERT – MEDICAL DEVICES – NETHERLANDS

Industry: Drug Delivery / Inhalation / Drug Combination / Medicinal / Pharma.

Location: Home/Office based Netherlands.

Salary: 45-65k Sterling.

Bonus: 10-15%.

Training: Yes (Full).

Type: Permanent.

Typical:

Today you are working from home reviewing fatigue test data on a new drug eluting stent design of one of your customers. Tomorrow you audit the manufacturing facilities of a large manufacturer of PTCA catheters in Germany. Next week you present at a medical device regulatory conference in Sweden. As A Technical Lead, Scheme manager, Product expert and part of one of our global technology teams, you appreciate the dynamic of working in a mix of regulatory affairs, quality auditing and medical technology innovations. You enjoy an international working environment in a growing team of medical device experts, working with small start-up and large multi-national clients, a bit of travelling and reviewing the latest technologies.

Requirement: Currently recruiting Medical Device Technical Experts for the following device categories:

• Drug-delivery device/drug combination products.


• Implantable devices in the orthopaedic, dental, ophthalmic, IVD, Dialysis, Active devices, soft tissue implants, wound care and cardiovascular fields.


• Sterility Aseptic Sterile Manufacturing.


• Ophthalmics, contact lenses, eyecare.

Function of the position:

• As a technical expert assessing the manufacturer’s technical files and design dossiers;


• As a member of a team auditing a device manufacturer’s quality system;


• As a regulatory expert and scheme manager, managing a portfolio of clients with respect to services provides to them.

• Provide specialist pharmaceutical affairs, regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes;


• Deliver technical reviews and certification scheme management in support of CE marking;


• Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise relating to pharmaceuticals;


• Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel; and to

• Provide in-house and external training for device/drug combination products.

Qualifications and Experience:

Candidates will have medical device experience within an industrial, academic or clinical background.

Their qualifications will reflect a thorough understanding of the technological considerations and manufacturing processes relevant to the field in which they have worked.

Successful candidates will be motivated to perform detailed investigation of complex technical issues, have a desire to learn new disciplines, are strong communicators, and have strong analytical and organizational skills, and have the presence to make and explain difficult decisions if necessary.

DRUG DELIVERY / COMBINATION PRODUCTS / INHALATION / FORMULATION / STERILE / PHARMA / PHARMACEUTICAL / ASTRA ZENECA / PFIZER / GSK / GLAXO / WYETH / PHARMACEUTICALS /GENERICS / MYLAN / REVIEWER / SOFT TISSUE / 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 / 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 / R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / INFUSION / BOSTON SCIENTIFIC / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCULAR / VASCULAR / MEDICAL DEVICES / 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 / senior engineer, development engineer, product development,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 / SCIENTIFIC / FORMULATION CE MARKING / CERTIFICATION / USA / UK / UNITED KINGDOM / LONDON / MILTON KEYNES / BEDFORDSHIRE / MIDLANDS / OXFORD / OXFORDSHIRE / CAMBRIDGESHIRE / BRISTOL /LONDON / KENT / SUSSEX / CAMBRIDGESHIRE / BEDFORD / HERTS/ HERTFORDSHIRE / INTERTEK / UL / BUCKS / BUCKINGHAMSHIRE / HEREFORSHRIE / STAFFORD / STAFFORDSHIRE / CHESHIRE / MANCHESTER / LANCASHIRE / LEEDS / YORK / YORKSHIRE / BIOLOGICAL / CHEMISTRY / OPHTHALMIC / CONTACT LENSE / BIOCHEMISTRY / UK / UNITED KINGDOM / LONDON / SOUTH / SOUTH EAST / NORTH WEST / ENGLAND / RELOCATE / MIDLANDS / OXFORD / HOME COUNTIES / MILTON KEYNES / SOUTH WEST /SOLUTIONS/SOFT TISSUE/MEDTRADE/CONVATEC/TISSUE SCIENCE/ITALY/ROME/MILAN/DEKRA/KEMA/UL/INTERTEK, Amsterdam, rotterdam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, drachten, Leeuwarden, Groningen, assen, leiden, holland