MEDICAL DEVICE PRODUCT EXPERT / PRODUCT SPECIALIST / REGULATORY AUDITOR

Posted 20 October by Bosch Global Associates Ltd

MEDICAL DEVICE PRODUCT EXPERT/PRODUCT SPECIALIST/REGULATORY AUDITOR

Locations: Anywhere Home Based Japan.

Salary: Negotiable Eur.

Work from Home/Remote: Yes.

Travel: Yes (0% during Covid19).

Bonus: 15% performance based and discretionary.

Training: 100% Yes Globally Recognised Training (Full).

Overview:

We currently have an exciting opportunity with our Global Medical Devices Client working as a Technical Product Specialist / Medical Device Auditor.

As a dedicated Technical Specialist, you will be responsible for reviewing the design dossiers of a wide range of Medical devices with the aim of determining whether the devices meet the requirements of the Medical Devices Directive and relevant harmonised standards.

You will write comprehensive audit reports which either support or reject the manufacturers application for CE marking based on the evidence provided.

Ultimately your work will determine whether or not a device has been demonstrated to be safe and effective, meets its intended use and can be awarded CE certification.

Your responsibilities will include, but are not limited to:

Assessment of Technical Documentation: Perform conformity assessments of regulatory submissions such as Design Dossiers and Technical Documentations to relevant safety principles and standard requirements.

Auditing (to limited extent): Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), MDSAP / Medical Device Single Audit Program (US, Canada, Brazil, Japan, Australia), and International quality system standards (e.g. ISO 13485).

Project Management: Provide project management for customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.

This job may be for you if have:

Minimum Degree Qualified - hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.

Three / Four years minimum work experience in design / product development / manufacturing engineering one of the following medical device product categories: Active Implantable Medical Devices, Acitve Devices, Non-Active devices, Orthopedics, Cardiovascular Products, Functional Safety and Software

A relevant Master degree substitutes one year and a relevant PhD degree substitutes up to three years of four years of work experience

Sound knowledge in regulatory requirements, e. g. MDD (93/42/EEC) and other related requirements

Sound knowledge in product-, technology- quality- or other related standards

Orientation towards the safety and performance of medical devices

Auditor according to ISO 13485 and MDD / AIMDD and CMDCAS and JGMP (a plus)

Sound knowledge in product-, technology- quality- or other related standards

Willingness to travel (domestic and international)

60601 / 60602 / ACTIVE DEVICES / ACTIVE IMPLANTABLES / AIMD / SOFT TISSUE / ELECTRICAL / ELECTRICAL / ELECTRONICS / PHYSICS / ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO SURGICAL / ELECTRO MECHANICAL / QA / QUALITY ASSURANCE / ISO13485 / 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 / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / RADITATION / BENELUX / SWEDEN / POLAND / BELGIUM / SWITZERLAND / FRANCE / GERMANY / EUROPE / 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 / California / North East / Minneapolis / Utah / Florida / Texas / New York / Carolina / Virginia / Pennsylvania / Ohio / Carolina / Toronto / San Francisco / Los Angeles / Utah / Nevada / Idaho / Montana / Nebraska / Dakota / Las Vegas / Oregan / Washington / Chicago / Iowa / Indiana / Michigan / New York / Toronto / Pennsylvania / Kentucky / New Jersey / Connecticut / Missisippi / Houstan / Texas / Alabama / Louisianan / Dallas / Arkansas / Missouri / Tennessee / Wyoming / Colorado / America / USA US / United States / neurostimulators / electronics design / validation / verification / active implantable / medical device prototypes / implantable stimulator / bioelectricity / bioelectrodes / design / biocompatibility / senior engineer / development engineer / product development / R&D Engineer / SURGICAL GLOVES / SCIENTIFIC / FORMULATION

Required skills

  • Biomedical
  • Medical Devices
  • Product Development
  • Regulatory Affairs
  • CE marking

Application questions

Minimum of 4 years hands-on medical device experience in manufacturing or product development?
OR Minimum of 4 years hands-on medical device experience in r&d/design or regulatory affairs?
OR Min. of 4 years hands-on experience in regulatory affairs/QMS Design/Auditing?
A cover letter detailing you meeting the requirements is a must?
Must provide a "a detailed" description of the types of products?

Reference: 40802800

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