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ACTIVE DEVICE TECHNICAL PRODUCT EXPERT NETHERLANDS

Location: Netherlands

Region: Amsterdam

Salary: 70-85k Euro

Type: Permanent

Conditions: Full Time

Reference: DB2028

Description

ACTIVE DEVICE TECHNICAL PRODUCT EXPERT – NETHERLANDS – 70-85k Eur

Industry: Active devices / Electromechanical / Electro-medical / surgical / 60601.

Job Title: Scheme Manager - Technical Specialist - Medical Device Expert - Certification Manager - Project Manager - Design Control Manager – R&D Manager – Design Engineer.

Location: ANYWHERE Home/Office Based.

Salary: 70-85k Eur.

Bonus: 15%.

Training: Yes (Full).

Type: Permanent.

Purpose of Position:

 

  • Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise.
  • Deliver technical reviews, scheme management and QMS assessment in support of the CE marking schemes.
  • Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel.
  • Provide “Technical Sales/Networking” support to the commercial team.

 

Key Responsibilities & Accountabilities:

 

  • Deliver Medical Device CE Marking technical review, scheme management and ISO 13485 / 60601 QMS assessment services as a fully integrated member of the O&D Team.
  • Work with O&D team and other team leaders as required to provide QMS assessment within area of expertise.
  • Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge.

 

Knowledge / Skills / Abilities:

 

  • BSc degree or PhD in a discipline relevant to medical device manufacture and use, or equivalent qualification.
  • Thorough knowledge of the design and development of medical devices 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 discipline: Active Devices.
  • Thorough knowledge of Medical Device regulation.
  • Concepts and intent of Product Certification and service orientation.
  • A team player good at relationship building internally and externally.
  • Broad technical understanding of client industry products.

 

 

REVIEWER / 60601 / 60602 / ACTIVE DEVICES / ACTIVE IMPLANTABLES / AIMD / SOFT TISSUE / ELECTRICAL / 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 / 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 / Amsterdam, rotterdam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, drachten, Arnhem, Leeuwarden, Groningen, assen, leiden, holland, arnhem, nederland, nijmegen, belgium, brussels, germany, FRANCE / PARIS

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