Technical Product Specialist/ Expert - EMEA

Discipline: Medicinal / Combination products.

Job Title: Scheme Manager - Technical Specialist - Certification Manager - Project Manager - Design Control Manager - Formulation Manager - Product Development Manager - R&D Manager

Location: Home/Office based UK.

Bonus: 15%.

Training: Yes (Full).

Type: Permanent.

Organisation: a Notified Body for the Medical Device Industry.

Responsibilities:

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.

The Key Responsibilities & Accountabilities are to:

Lead communications with EU Competent Authorities for medicinal consultations on behalf of clients;

Deliver Medical Device CE Marking technical reviews and certification scheme management;

Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge.

Qualifications:

The ideal candidate to fill this role will have the following qualifications, skills and experience:

BSc, MSC or PhD degree in a discipline relevant to medical device manufacture and use, or equivalent qualification;

Life science qualification, ideally pharmaceutical or QP qualified;

Thorough knowledge of the design and development of products in area of experience, including the principles of design control, risk management and performance or clinical evaluation;

Experience in one or more of the following disciplines: devices which incorporate a medicinal substance, pharmaceutical processes and documentation, clinical trials, active pharmaceutical ingredients, medicinal chemistry, pharmacy law, ethics, formulation, biopharmaceutical analysis, pharmacology, process validation, regulatory documentation, analytical methods, technology transfer

Understand the concepts and intent of Product Certification and service orientation;

Knowledge of business processes and the application of quality management standards;

Conceptual and analytical thinking, efficiency and results orientation;

A team player good at relationship building internally and externally.

DRUG DELIVERY / COMBINATION PRODUCTS / INHALATION / FORMULATION / STERILE / PHARMA / PHARMACEUTICAL / ASTRA ZENECA / MEDICINAL / AESICA / PHARMATERIALS / PFIZER / GSK / GLAXO / WYETH / PHARMACEUTICALS /GENERICS / MYLAN / REVIEWER / 60601 / 60602 / ACTIVE DEVICES / ACTIVE IMPLANTABLES / AIMD / SOFT TISSUE / ELECTRICAL / 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 / RISK ASSESSMENT / BIOCOMPATIBILITY / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / 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 / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCULAR / VASCULAR / MEDICAL DEVICES / ELECTRO 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 LA

Required skills

  • Formulation
  • Medicinal Chemistry
  • Pharmaceutical
  • Product Development
  • R&D

Application question

Do you have 4 years R&D or product development expertise in combination products?

Reference: 30479645

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