MEDICAL DEVICE PRODUCT EXPERT / PRODUCT SPECIALIST / REGULATORY AUDITOR
Posted 15 January 2021 by Bosch International Associates Ltd
€40,000 – €65,000 every year, negotiable Zhejiang, China Everlasting, full-time Be one of many first ten candidates
View all jobs
Posted by Bosch International Associates Ltd
MEDICAL DEVICE PRODUCT EXPERT/PRODUCT SPECIALIST/REGULATORY AUDITOR
Areas: Anyplace House Primarily based China.
Wage: Negotiable Eur.
Work from House/Distant: Sure.
Journey: Sure (0% throughout Covid19).
Bonus: 15% efficiency based mostly and discretionary.
Coaching: 100% Sure Globally Recognised Coaching (Full).
Overview:
We at present have an thrilling alternative with our International Medical Units Consumer working as a Technical Product Specialist / Medical Gadget Auditor.
As a devoted Technical Specialist, you’ll be chargeable for reviewing the design dossiers of a variety of Medical gadgets with the intention of figuring out whether or not the gadgets meet the necessities of the Medical Units Directive and related harmonised requirements.
You’ll write complete audit reviews which both assist or reject the producers software for CE marking based mostly on the proof offered.
Finally your work will decide whether or not or not a tool has been demonstrated to be protected and efficient, meets its supposed use and might be awarded CE certification.
Your tasks will embody, however usually are not restricted to:
Evaluation of Technical Documentation: Carry out conformity assessments of regulatory submissions reminiscent of Design Dossiers and Technical Documentations to related security rules and customary necessities.
Auditing (to restricted extent): Carry out regulatory audits of shoppers per European Medical Gadget Directives (AIMD, MDD, IVDD), MDSAP / Medical Gadget Single Audit Program (US, Canada, Brazil, Japan, Australia), and Worldwide high quality system requirements (e.g. ISO 13485).
Undertaking Administration: Present undertaking administration for purchasers. Undertaking administration doubtlessly consists of issuing quotes, coordinating a number of tasks, coordinating audit crew, and answering shopper questions.
This job could also be for you if have:
Minimal Diploma Certified – maintain a BSc, Grasp’s diploma or PhD (or equal qualification) in a self-discipline related to medical gadget manufacture and use.
Three / 4 years minimal work expertise in design / product growth / manufacturing engineering one of many following medical gadget product classes: Energetic Implantable Medical Units, Acitve Units, Non-Energetic gadgets, Orthopedics, Cardiovascular Merchandise, Purposeful Security and Software program
A related Grasp diploma substitutes one 12 months and a related PhD diploma substitutes as much as three years of 4 years of labor expertise
Sound information in regulatory necessities, e. g. MDD (93/42/EEC) and different associated necessities
Sound information in product-, technology- quality- or different associated requirements
Orientation in direction of the security and efficiency of medical gadgets
Auditor in accordance with ISO 13485 and MDD / AIMDD and CMDCAS and JGMP (a plus)
Sound information in product-, technology- quality- or different associated requirements
Willingness to journey (home and worldwide)
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 / Coronary heart valves / transcatheter / aortic valves / belly 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 / lively implantable / medical gadget prototypes / implantable stimulator / bioelectricity / bioelectrodes / design / biocompatibility / senior engineer / growth engineer / product growth / R&D Engineer / SURGICAL GLOVES / SCIENTIFIC / FORMULATION
Required abilities
Biomedical Medical Units Product Growth Regulatory Affairs CE marking
Software questions
Minimal of four years hands-on medical gadget expertise in manufacturing or product growth? Sure NoOR Minimal of four years hands-on medical gadget expertise in r&d/design or regulatory affairs? Sure NoOR Min. of four years hands-on expertise in regulatory affairs/QMS Design/Auditing? Sure NoA cowl letter detailing you assembly the necessities is a should? Sure NoMust present a “an in depth” description of the forms of merchandise? Sure No
Reference: 40802818
Financial institution or fee particulars ought to by no means be offered when making use of for a job. For info on learn how to keep protected in your job search,
