ORTHOPAEDIC TECHNICAL PRODUCT EXPERT - "SHOULDER"

Posted 9 April by Bosch Global Associates Ltd Easy Apply

ORTHOPAEDIC TECHNICAL PRODUCT EXPERT - MEDICAL DEVICES - "SHOULDER"

Industry: Implants / Orthopaedic / Soft Tissue/ Tissue Engineering / Dental.

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, UK.

Salary: 45-65k Sterling.

Bonus: 10%.

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 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 disciplines: Orthopaedic implants (specifically Shoulder devices); Dental implants; General orthopaedic & non-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 / Heart valves, transcatheter, aortic valves, abdominal aortic aneurysms, grafts, Coronary, peripheral stents, Cerebral, Coils, Ablation, catheters, America, neurostimulators, electronics design, validation, verification, active implantable medical device prototypes, implantable stimulator, bioelectricity, bioelectrodes, design and analysis of experiments, biomedical signal processing, biocompatibility, senior engineer, development engineer, product development, design, 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

Required skills

  • Health Care
  • Medical Devices
  • Pharmaceutical

Reference: 30479678

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