Product Specialist / Product Expert / QMS Regulatory Auditor - ANYWHERE GERMANY

Posted 20 October by Bosch Global Associates Ltd


Product Specialist / Product Expert / QMS Auditor / Regulatory Auditor

Location: Bavaria-Area, Germany.

Type: Permanent Full Time.

Salary guideline: Negotiable depending on experience.

Business Travel: Yes, approx. 35%.

Product Type and Experience: Active or Non Active Medical Devices and "min. 4 years expertise".

Purpose: Technical File Reviews and QMS Assessment.

The position:

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, MDR), 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.

- Conscientious assessment of quality management systems and technical documentation during announced and unannounced audits.

- Inspections at manufacturers of active or non active medical devices according to EU guidelines and quality management standards according to the specifications of other regulatory systems.

- Continuous support of evaluation and certification projects including preparation of the corresponding documentation and communication with customers.

- Dedicated collaboration and independent project work in the context of supporting national and international customers.

Education/Qualifications:

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

#testing #manufacturing #bioclinical #medicaldevices #medicaldevice #ivd #clinical #diagnostics #consultant #productexpert #productspecialist #riskmanager #qamanager #qualityassurance #qa #qamanager #projectmanager #schememanager #certification #regulatory #activedevices #nonactivedevices #regulatoryaffairs #mdr #manager #teamleader #medicaltechnology #medicaldirectives #marketapproval #marketaccess #filereviews #filereviewer #technicalfiles #notifiedbody #Germany #bielefeld #hanover #kassel #rostock #bonn #dresden #essen #dusseldorf #munster #aachen #koblenz #hanover #bremen #hamburg #leipzig #dortmund #munich #berlin #Frankfurt #hamburg #cologne #medtech #stuttgart #zurich #konstanz #salzburg #augsburg #ulm #neustadt #regensburg #straubing #rosenheim #kempten #konstanz #karlsruhe #heidelberg #frankfurt #wurzburg #bamberg #bayreuth #ingolstadt #passau #medicaltechnology #quality #mdr #ivdr #ivd #testengineer #testing #test #engineer #engineering #productsafety #safety #EN60601 #iso14971 #assessment #assessor #ISO13485 #medicaldevice #electromedical #activedevices #activeimplant #highriskdevices #medicaltechnology #meddev #medtech #r&d #diagnostics #researchanddevelopment #productdevelopment #productdesign #research #design #MDD #MDR #MDSAP #IVD #IVDR #certification #cemarking #cesubmission #FDA #designcontrol #designassurance #technicalfilesreviews #biomedical #engineer #engineering #biomedicalengineering #lifesciences #lifescience #Germany #bavaria #nuremburg #europe #jobs #careers #job #career

Required skills

  • Medical Devices
  • Medical Diagnostics
  • Quality Assurance
  • Regulatory Affairs
  • IVD

Application questions

Do you have a min. of 4 years relevant IVD industry experience?
Do you speak German - min. intermediate level?
MUST provide Cover Letter expressing 1. interest and 2. relevant expertise?
Are you degree educated - qualified?
Have you read the Job advert and are you ok with business travel up to 50%?

Reference: 40837072

Bank or payment details should never be provided when applying for a job. For information on how to stay safe in your job search, visit SAFERjobs.

Report this job